Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.
Kunkler IH, Russell NS, Anderson N, Sainsbury R, Dixon JM, Cameron D, Loncaster J, Hatton M, Westenberg H, Clarke J, McCarty H, Evans R, Geropantas K, Wolstenholme V, Alhasso A, Woodings P, Barraclough L, Bayman N, Welch R, Muturi F, McEleney T, Burns J, Riddle K, Macdonald E, Dunlop J, Sergenson N, van Tienhoven G, Taylor KJ, Bartlett JMS, Piper T, Velikova G, Aird E, Chua B, Hurkmans C, Venables K, Williams LJ, Thomas JS, Hanby AM, Maclennan M, Cleator S, Verghese ET, Li Y, Wang S, Canney P, SUPREMO Trial Investigators, Sunil
- DOI
- 10.1056/NEJMoa2412225
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- Exported
- 2026-09-21
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/a0079fe1-cc65-491e-a0b6-8c051f10e4fe is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ReportingBiological variables not met−0.5★
- ReportingKey resources not met−0.5★
- ReportingData & code availability not met−0.5★
- StatisticsPrinted percentage does not match its own count (capped)−0.25★
- 01Biological variables not reported
The paper reports age and sex (women), but does not provide justification for the single-sex design, nor report weight, health status, race/ethnicity, or comorbidities.
“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer”
MethodsFind in source - 02Key resources not identified
The investigational product (chest wall irradiation) is described by dose but not by equipment manufacturer or source, and no statistical software is identified, leaving all applicable sub-criteria inadequate.
“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”
MethodsFind in source - 03Data and code not shared
The paper does not include a data availability statement. Trial registration is provided, but no information on how to access the data is given.
“ISRCTN registration is 61145589.”
MethodsFind in source - 04Printed percentage does not match its own count
65.8% does not match the reported count 195/295
“Most deaths (195/295, 65.8%) were due to breast cancer (S3.2)”
Most deaths (195/295, 65.8%) were due t…Find in source - 05Internal contradictions in the reported numbers
In the distant metastasis-free survival sentence, the reported event count (176) is inconsistent with the reported percentage (23.8%): 176/808 = 21.8%, whereas 23.8% of 808 = 192. The 23.8% value matches the disease-free survival event count (192/808), suggesting a transcription error.
“For distant metastasis-free survival we observed 176 metastatic events including death with irradiation (23.8%) and 166 events (20.8%) without irradiation”
ResultsFind in source
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 SUPREMO trial is a methodologically sound, well-reported randomized phase 3 study with a clear scientific premise, rigorous randomization, an a priori power calculation, and adequate ethics documentation. Its main weaknesses are the absence of a data availability statement, a demonstrable internal inconsistency in a secondary-endpoint percentage (176 events reported as 23.8% instead of 21.8%), and minor transparency gaps (no explicit CONSORT citation, no COI statement, no statistical software named, incomplete demographic reporting).
Three independent reviewer runs of the same model were synthesized; they agreed on most dimensions but diverged on biological variables (fail/pass/warn → warn) and key resources (fail/not applicable/not applicable → not applicable). The statistical analysis dimension was downgraded from pass to warn based on the independently flagged internal contradiction (176/808 ≠ 23.8%), which the reviewers missed. Statistics verification covered only 2 recomputable tests; the rest were not machine-verified. Citation check found 0 retracted and 0 not-found references among 38 checked.
Numerical inconsistencies
2 findings · worst mediumValues 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
- Printed percentage does not match its own countRecomputed
Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks. 1 printed percentage that does not match its own count.
- PERCENT65.8% does not match the reported count 195/295
“Most deaths (195/295, 65.8%) were due to breast cancer (S3.2)”
Most deaths (195/295, 65.8%) were due t…Find in source
- CONSISTENTreported p = .800 · recomputed p = .739Reviewers 1, 2, 3Primary endpoint overall survival: HR vs 1.0
“There was no evidence of a difference in overall survival, 81.4% with CWI, 81.9% without CWI (10-year Kaplan-Meier estimates), hazard ratio (HR) of 1.04; 95% confidence interval [CI], 0.82 to 1.30, (p=0.80).”
Taken as given: The HR is on the log scale; The CI is two-sided at 95%; The p-value is from a Wald test of the Cox modelMethod: pCI function: computes two-tailed p-value from an estimate and its 95% CI on the log scale for a ratio.How we recomputed it: pCI(1.04, 0.82, 1.30, 1)
- mediuminternal contradictionIn the distant metastasis-free survival sentence, the reported event count (176) is inconsistent with the reported percentage (23.8%): 176/808 = 21.8%, whereas 23.8% of 808 = 192. The 23.8% value matches the disease-free survival event count (192/808), suggesting a transcription error.
“For distant metastasis-free survival we observed 176 metastatic events including death with irradiation (23.8%) and 166 events (20.8%) without irradiation”
ResultsFind in source - lowinternal contradictionThe abstract reports disease-free survival with CWI as 78.2%, while the Results section reports 76.2% for the same arm; the non-irradiated arm is consistent at 75.5% in both places.
“Disease-free survival was 78.2% with CWI and 75.5% without CWI; HR 0.97; 95% CI, 0.79 to 1.18”
AbstractFind in source
Overstated conclusions
1 finding · worst lowConclusions 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
12 major claims checked against the paper's own evidence: all adequately supported.
- partialReviewer 1The trial provides robust data on the impact of radiotherapy, despite the lower than planned number of events.The authors acknowledge the lower event rate but argue the data are robust; however, the reduced power is a limitation.Evidence: Discussion: 'We consider that the trial provides robust data on the impact of radiotherapy, despite the lower than planned number of events due to the improved survival.'
“We consider that the trial provides robust data on the impact of radiotherapy, despite the lower than planned number of events due to the improved survival.”
Discussion ¶1Find in source - partialReviewer 2Triple-negative breast cancer patients had worse overall survival with chest wall irradiation.The subgroup HR of 2.05 (95% CI 1.05-4.02) supports the direction of the claim, but it is a post-hoc-style subgroup with likely low numbers, and the authors themselves caution that 'This finding could be due to low numbers'.Evidence: Subgroup analysis by molecular subtype: TNBC HR 2.05, 95% CI 1.05-4.02.
“The exception was patients with triple negative breast cancer (TNBC), who appeared to have worse overall survival with CWI (HR 2.05; 95% CI, 1.05 to 4.02)”
DiscussionFind in source - partialReviewer 3Triple-negative breast cancer patients may have worse overall survival with CWI.The subgroup analysis shows HR 2.05, 95% CI 1.05-4.02, but the authors note that this could be due to low numbers and the finding is exploratory, so the claim is only partially supported.Evidence: Subgroup analysis by molecular subtype: HR 2.05, 95% CI 1.05-4.02 for TNBC patients.
The exception was patients with triple negative breast cancer (TNBC), who appeared to have worse overall survival with CWI (HR 2.05; 95% CI, 1.05 to 4.02).
Resultsreviewer’s wording - supportedReviewer 1Chest wall irradiation did not improve overall survival.The primary endpoint result (HR 1.04, 95% CI 0.82-1.30, p=0.80) clearly supports this claim.Evidence: Primary endpoint: HR 1.04, 95% CI 0.82-1.30, p=0.80
“There was no evidence of a difference in overall survival, 81.4% with CWI, 81.9% without CWI (10-year Kaplan-Meier estimates), hazard ratio (HR) of 1.04; 95% confidence interval [CI], 0.82 to 1.30, (p=0.80).”
AbstractFind in source - supportedReviewers 1, 2Chest wall irradiation reduced chest wall recurrence.The result (HR 0.45, 95% CI 0.20-0.99) shows a reduction, though the absolute difference is small and the CI is wide.Evidence: Secondary endpoint: HR 0.45, 95% CI 0.20-0.99
“A reduction in chest wall recurrence with irradiation (HR 0.45; 95% CI, 0.20 to 0.99) was seen”
AbstractFind in source - supportedReviewer 1There did not appear to be a differential effect of CWI on overall survival in patients with pN0 or pN1 disease.The subgroup analysis shows no differential effect (HR 0.82, 95% CI 0.63-1.05 for pN1 relative to pN0).Evidence: Subgroup analysis: HR 0.82, 95% CI 0.63-1.05 for pN1 vs pN0
“We observed no differential effect of irradiation on overall survival related to nodal status”
ResultsFind in source - supportedReviewer 1Subgroup analysis by molecular subtype suggested a worse outcome for TNBC patients following radiotherapy.The data show a significant HR of 2.05 (95% CI 1.05-4.02) for TNBC, supporting the claim, though the authors note it could be due to low numbers.Evidence: Subgroup analysis: HR 2.05, 95% CI 1.05-4.02 for TNBC
“The exception was patients with triple negative breast cancer (TNBC), who appeared to have worse overall survival with CWI (HR 2.05; 95% CI, 1.05 to 4.02)”
ResultsFind in source - supportedReviewer 2Chest wall irradiation did not improve overall survival in intermediate-risk early breast cancer patients treated by mastectomy.The primary endpoint analysis directly supports the claim: HR 1.04, 95% CI 0.82-1.30, p=0.80, with identical 10-year survival estimates (81.4% vs 81.9%).Evidence: Primary endpoint results: 295 events, 10-year OS 81.4% with CWI vs 81.9% without, HR 1.04 (95% CI 0.82-1.30), p=0.80.
“there was no evidence of a difference in overall survival with chest wall irradiation: estimated at 10 years as 81.4% with irradiation, 81.9% without irradiation”
AbstractFind in source - supportedReviewer 2The trial provides no evidence to support continued use of adjuvant chest wall irradiation in most intermediate-risk patients.Supported by the null primary result and the minimal (<2%) absolute difference in chest wall recurrence; the authors appropriately frame this as absence of evidence of benefit while acknowledging small effects cannot be excluded.Evidence: Null overall survival, disease-free survival, and distant metastasis-free survival results; <2% absolute difference in chest wall recurrences.
“SUPREMO provides no evidence to support continued use of adjuvant CWI in most patients with intermediate-risk early breast cancer treated by mastectomy and contemporary adjuvant systemic therapy.”
DiscussionFind in source - supportedReviewer 3Chest wall irradiation did not improve overall survival in this phase 3 trial.The primary endpoint analysis shows HR 1.04, 95% CI 0.82-1.30, p=0.80, with 10-year survival estimates of 81.4% vs 81.9%, supporting the claim.Evidence: Primary endpoint analysis: HR 1.04, 95% CI 0.82-1.30, p=0.80.
There was no evidence of a difference in overall survival with chest wall irradiation: estimated at 10 years as 81.4% with irradiation, 81.9% without irradiation; hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.
Resultsreviewer’s wording - supportedReviewer 3Chest wall irradiation reduced chest wall recurrence but with a small absolute difference.The paper reports a reduction in chest wall recurrence with HR 0.45, 95% CI 0.20-0.99, and an absolute difference of <2%, which is consistent with the claim.Evidence: Secondary endpoint analysis: 29 chest wall recurrences, 9 with CWI vs 20 without, HR 0.45, 95% CI 0.20-0.99, absolute difference <2%.
Only 29 chest wall recurrences occurred, 20 (2.5%) without and 9 (1.1%) with irradiation, an absolute difference of <2%. A reduction in chest wall recurrence with irradiation (HR 0.45; 95% CI, 0.20 to 0.99) was seen.
Resultsreviewer’s wording - supportedReviewer 3No differential effect of CWI on overall survival by nodal status or age group.Pre-planned subgroup analyses show no significant interaction for nodal status or age group, with confidence intervals crossing 1, supporting the claim.Evidence: Subgroup analyses: forest plots and Kaplan-Meier curves show no differential effect by nodal status or age.
We observed no differential effect of irradiation on overall survival related to nodal status. ... There was no differential effect of CWI on primary and secondary outcomes by age-group.
Resultsreviewer’s wording
Data authenticity concerns
None foundAn 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
3 findings · worst highRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Biological variables not reportedAssessed
- Data and code not sharedAssessed
- Key resources not identifiedAssessed
The introduction cites the Danish and Canadian trials, the EBCTCG meta-analysis, and notes that the evidence base may not be applicable due to improvements in systemic therapy. The limitations of prior research are acknowledged. The hypothesis follows logically from the cited evidence.
“Landmark Danish and Canadian randomized controlled trials (RCTs) reported in 1997-99 showed that post-mastectomy radiotherapy for stages II and III reduced the risk of locoregional recurrence and improved 10-year survival in women with nodal metastases.”
“Hence, the role of post-mastectomy radiotherapy in patients with 1-3 involved axillary nodes is uncertain as reflected in differing guidelines”
“Adjuvant systemic therapy in these trials is now considered sub-optimal.”
“Landmark Danish and Canadian randomized controlled trials (RCTs) reported in 1997-99 showed that post-mastectomy radiotherapy for stages II and III reduced the risk of locoregional recurrence and improved 10-year survival in women with nodal metastases.”
“Subsequently, major improvements in systemic therapy and reductions in breast cancer mortality () challenge the applicability of the evidence base for post-mastectomy radiotherapy to current practice.”
“Adjuvant systemic therapy in these trials is now considered sub-optimal.”
Randomization used permuted blocks with varying block length and center stratification. The unit of randomization is the individual patient. Inclusion and exclusion criteria are well-defined. A priori power analysis was performed and revised. The analysis is ITT. However, blinding is not mentioned; given the nature of the intervention, an open-label design is implied but not stated as a rationale.
“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”
“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”
“The sample size to detect this difference would be 1600 patients allowing for 5% loss to follow up (or 609 events).”
“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”
“Revised sample size and powering were based on an assumption of a difference of 7% in overall survival (56% without CWI vs 63% with CWI) between the arms of the trial (corresponding to a hazard ratio of 1.255) with 80% power at the 0.05 level of significance.”
Table 1 reports age, but not weight or health status. Demographics are limited to age and sex; race/ethnicity and comorbidities are not reported. Since the study only includes women, a scientific justification for excluding men is required but not provided.
“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer”
“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer”
“Age (years) | 55.0 (48.0, 64.0) | 54.0 (47.0, 64.0)”
“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer without distant metastases”
The paper states that the protocol received UK ethical approval with a reference number and equivalent approval in non-UK jurisdictions. Written informed consent was obtained from all patients. The trial was conducted in accordance with Good Clinical Practice, satisfying regulatory compliance.
“The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.”
“All patients provided written informed consent.”
“The Scottish Clinical Trial Research Unit in Edinburgh provided the data management and the remote monitoring to ensure adherence with Good Clinical Practice.”
“The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.”
“All patients provided written informed consent.”
“The Scottish Clinical Trial Research Unit in Edinburgh provided the data management and the remote monitoring to ensure adherence with Good Clinical Practice.”
“The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.”
“All patients provided written informed consent.”
“The Scottish Clinical Trial Research Unit in Edinburgh provided the data management and the remote monitoring to ensure adherence with Good Clinical Practice.”
The intervention is radiotherapy, but the paper does not specify the radiation delivery equipment (e.g., linear accelerator vendor) or its source. As a device trial, the investigational product should be identified with manufacturer/source in addition to dose/regimen. No statistical software is named in the analysis. No other key biological or chemical resources are used in this human RCT.
“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”
“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”
“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”
The primary analysis uses Cox proportional hazards models with Schoenfeld residuals to check proportional hazards. Exact p-values and 95% CIs are reported for all endpoints. Data are presented with Kaplan-Meier plots and detailed tables. The statistical software used is not reported, which is a minor omission.
“Analysis of overall survival and other time-to-event outcomes was based on the calculation of 95% confidence intervals for the hazard ratios from a Cox proportional hazards model”
“Proportional hazards checks were made for every covariate by Schoenfeld residuals score tests (S4.3).”
“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.”
“analysis of overall survival and other time-to-event outcomes was based on the calculation of 95% confidence intervals for the hazard ratios from a Cox proportional hazards model”
“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80”
“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.”
The paper mentions the trial registration number (ISRCTN 61145589) but does not state where the data can be accessed. There is no data availability statement. No custom code is mentioned, so code sharing is not applicable.
“ISRCTN registration is 61145589.”
“The TRANS-SUPREMO tissue archive is available for investigating prognostic and predictive biomarkers.”
The paper provides comprehensive methods, including protocol amendments. Trial registration is given (ISRCTN 61145589). All primary and secondary endpoints are reported, with QoL and cost-effectiveness noted for separate publication. Limitations are discussed in detail. The conclusions are proportional to the evidence. However, no CONSORT or other reporting guideline is referenced, and a formal conflict-of-interest statement is absent.
“ISRCTN registration is 61145589.”
“ISRCTN registration is 61145589.”
“Our trial has some limitations. First, SUPREMO was initiated nearly two decades ago.”
“Supported by UK MRC and NIHR, EORTC Academic Research Fund and Breast Cancer Group, Dutch Cancer Society, Cancer Australia, Breast Cancer Institute Endowment Fun”
“ISRCTN registration is 61145589.”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
None foundReferences 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 38 references by DOI: 34 verified — 4 no DOI (shown, not verified).
- NO DOIRadiotherapy and chemotherapy in high-risk breast cancerNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOINCCN Guidelines Version 4.2025 Invasive Breast CancerNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIEvidence reviews for postmastectomy radiotherapy: Early and locally advanced breast cancer: diagnosis and management: Evidence review INo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOITreatment of the Regional Nodal Basins for Invasive Breast CancerNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 0 live.
- datahttps://www.nejm.org/UNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
Copyediting
1 finding · worst lowWording, consistency and formatting errors that need correcting before submission.
- Wording or formatting errors that need correctingAssessed
13 copyedit issues flagged (2 major): mostly consistency, other, clarity.
- MAJORconsistencyAbstract vs Results, Secondary endpoints“Disease-free survival was 78.2% with CWI and 75.5% without CWI”→ Align with Results value of 76.2% for the CWI arm (192/808 events = 23.8% → 76.2%).Abstract reports 78.2% for DFS with CWI; Results reports 76.2% for the same arm.
- MAJORconsistencyResults, Secondary endpoints“we observed 176 metastatic events including death with irradiation (23.8%)”→ Change 23.8% to 21.8% (176/808), or correct the event count, since 176 events = 21.8%.23.8% corresponds to 192 events, not 176; the 23.8% value belongs to the disease-free survival count.
- MINORotherAbstract“pmc 1”→ Remove 'pmc 1' from the beginning of the abstract.Seems like a journal identifier that should be removed.
- MINORtypoDiscussion“Diagram Figure 2”→ Remove 'Diagram' before 'Figure 2' or format properly.The word 'Diagram' appears before the figure captions, likely a formatting error.
- MINORconsistencyResults“We observed 295 primary endpoint events (150 in the irradiation group and 145 in the no irradiation group).”→ Consider using consistent terminology: 'CWI' instead of 'irradiation'.The paper uses 'CWI' and 'irradiation' interchangeably; consider using one term consistently.
- MINORclarityMethods“The protocol specified guidelines for pathology, surgery, radiation and adjuvant systemic therapy.”→ Add a comma after 'radiation' for clarity.Minor punctuation.
- MINORgrammarAbstract / title block“behalf of the SUPREMO trial investigators”→ Insert 'On' before 'behalf'.Missing preposition.
- MINORgrammarResults, Pre-planned sub-group analyses“gives the Kaplan-Meier plots for overall survival by nodal status”→ Use 'Figures/Table give' or restructure to avoid a dangling subject.Subject-verb agreement with figure references.
- MINORclarityAbstract“Trial Reg:”→ Complete the registration number or remove the placeholder.Registration number appears as an incomplete label in the abstract.
- MINORotherResults, Pre-planned sub-group analyses“and .”→ Fill in the missing cross-references to figure/table numbers.Several dangling 'and .' reference placeholders suggest missing figure citations.
- MINORotherIntroduction, paragraph 2“()”→ Insert reference numbers or identifiers.Empty parentheses appear where references are expected.
- MINORconsistencyMethods, Statistical analysis“The null hypothesis was that there is no effect of CWI on overall survival...”→ Consider rephrasing to 'The null hypothesis was that CWI has no effect on overall survival...' for clarity.Minor phrasing issue.
- MINORclarityResults, Table 1 footnote“Percentages are rounded to 1 decimal place (which may not permit exact summation to 100%).”→ This is acceptable as a note.No change needed, but note the rounding.
This published trial is methodologically robust in design and primary analysis, but an informed reader should weigh the demonstrable internal inconsistency in the secondary-endpoint percentage (176 events reported as 23.8% instead of 21.8%) and the abstract/results disease-free-survival discrepancy (78.2% vs 76.2%) — both warrant an erratum/correction. The absence of a data availability statement, explicit CONSORT citation, COI declaration, and statistical software identification are transparency gaps that should be noted when weighing the evidence; an independent re-analysis is not warranted by these findings, but the reported secondary-endpoint numbers should not be taken at face value until corrected.
- 1.HIGHstatisticsCorrect the internal inconsistency in Results, Secondary endpoints: '176 metastatic events ... (23.8%)' should be 21.8% (176/808), or correct the event count/present the correct denominator.This is a demonstrable arithmetic error (176/808 = 21.8%, not 23.8%) that an informed reader or data auditor would catch; it warrants an erratum.
- 2.HIGHcopyeditReconcile the abstract vs Results disease-free survival value for the CWI arm (abstract reports 78.2%, Results reports 76.2% based on 192/808 events).The same endpoint is reported as two different values in the abstract and the Results section, which is a factual inconsistency requiring correction.
- 3.HIGHdata codeAdd a data availability statement to the paper (or a correction/note) describing a concrete access route for the trial dataset, e.g., a managed-access committee or platform (Vivli/YODA) with conditions.An individual-patient-data clinical trial with no data availability statement is a significant transparency gap that has been the subject of journal policy requirements.
- 4.HIGHreportingIdentify the statistical software and version used for the analyses (e.g., 'R version X, package survival' or 'SAS 9.4') in the Methods, Statistical analysis section.Reproducibility requires knowing the software and version; this is currently not reported.
- 5.HIGHreportingAdd an explicit conflicts-of-interest disclosure statement for all authors in the Funding/Acknowledgments section.A published trial with no COI statement leaves a reporting gap that journals and readers expect to be filled.
- 6.HIGHrigorAdd a brief statement in Methods (Treatment and trial procedures) stating that the radiotherapy vs no-radiotherapy design was open-label, with any assessor blinding used, and a rationale for the lack of patient blinding.Blinding is never addressed; for a procedural intervention an explicit open-label statement is expected for transparency.
- 7.HIGHrigorReport race/ethnicity and comorbidity data in Table 1 demographics, and add a sentence in Methods or Discussion justifying the female-only study population.Demographic reporting is incomplete (no race/ethnicity, no comorbidity), and the single-sex design is only implicitly justified.
- 8.MEDIUMreportingExplicitly cite the CONSORT reporting checklist or state that the CONSORT flow diagram was submitted per the checklist in Methods.A CONSORT diagram is shown but the checklist is not referenced, which is a minor reporting-guideline gap.
- 9.MEDIUMrigorReport the manufacturer/model of the linear accelerator(s) used for chest wall irradiation in Methods, Treatment and trial procedures.While the dose/fractionation is described, two reviewers flagged the absent equipment source as a replicability concern.
- 10.MEDIUMcopyeditFix mechanical copyedit issues: remove 'pmc 1' from the abstract, remove 'Diagram' before 'Figure 2', complete the 'Trial Reg:' placeholder, and fill dangling 'and .' / '()' reference placeholders in Results and Introduction.These are visible formatting and placeholder errors that detract from a published paper's professionalism.
- 11.LOWdata codeAdd a note on availability of the trial protocol and statistical analysis plan (e.g., reference to the protocol publication) and consider depositing a de-identified dataset or aggregate data in a repository.Further enhancing data sharing would strengthen the transparency of this public-good trial, though it is not strictly required.
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.”
- 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.
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.