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
- 2026-08-15
- Engine
- 7.39.0
- 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/23280d6d-0e5e-4b58-8fe5-ef681b06a9d4 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern−0.5★
- StatisticsPrinted percentage does not match its own count (capped)−0.25★
- ReportingData & code availability partially met−0.25★
- No data or code availability links were detected to verify.
- 01Printed percentage does not match its own count
65.8% does not match the reported count 195/295
“195/295, 65.8%”
Primary endpointFind 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.
This is a well-conducted and well-reported phase 3 randomized trial with rigorous design, clear ethical approvals, and transparent reporting. The main weakness is the lack of a concrete data availability statement and code sharing, which is a common gap in clinical trial publications.
Both reviewers independently scored all eight dimensions and agreed on all statuses; no divergence was present. The study type is interventional (randomized controlled trial). Non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded from scoring. The statistics verification covered only a subset of reported tests; the one inconsistent test was not identified, so it does not affect the pass status.
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.
- Printed percentage does not match its own countRecomputed
- Internal contradictions in the reported numbersAssessed
Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks. 1 printed percentage that does not match its own count.
- PERCENT65.8% does not match the reported count 195/295
“195/295, 65.8%”
Primary endpointFind in source
- CONSISTENTreported p = .800 · recomputed p = .739Reviewers 1, 2Primary endpoint HR p-value from CI
“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.”
Taken as given: The HR is 1.04 and the 95% CI is 0.82 to 1.30.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the HR and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(1.04, 0.82, 1.30, 1) - CONSISTENTreported p = .049 · recomputed p = .050Reviewers 1, 2Chest wall recurrence HR p-value from CI
“HR 0.45; 95% CI, 0.20 to 0.99.”
Taken as given: The HR is 0.45 and the 95% CI is 0.20 to 0.99.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the HR and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.45, 0.20, 0.99, 1) - CONSISTENTreported p = .600 · recomputed p = .587Reviewers 1, 2Distant metastasis-free survival HR p-value from CI
“HR 1.06; 95% CI, 0.86 to 1.31.”
Taken as given: The HR is 1.06 and the 95% CI is 0.86 to 1.31.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the HR and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(1.06, 0.86, 1.31, 1) - CONSISTENTreported p = .800 · recomputed p = .766Reviewers 1, 2Disease-free survival HR p-value from CI
“HR 0.97, 95% CI, 0.79 to 1.18”
Taken as given: The HR is 0.97 and the 95% CI is 0.79 to 1.18.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the HR and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.97, 0.79, 1.18, 1) - CONSISTENTreported p = .060 · recomputed p = .079Reviewer 1Lung toxicity OR p-value from CI
“OR = 2.59; 95% CI, 0.97 to 8.12”
Taken as given: The OR is 2.59 and the 95% CI is 0.97 to 8.12.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the OR and its 95% CI using the normal approximation for the log odds ratio.How we recomputed it: pCI(2.59, 0.97, 8.12, 1)
- lowinternal contradictionThe abstract reports 10-year disease-free survival as 78.2% with CWI and 75.5% without CWI, but the results section reports 76.2% with CWI and 75.5% without CWI.
Disease-free survival was 78.2% with CWI and 75.5% without CWI; HR 0.97; 95% CI, 0.79 to 1.18, and distant metastasis-free survival was 78.2% with CWI and 79.2% without CWI; HR 1.06; 95% CI, 0.86 to 1.31. ... Ten-year estimated disease-free survival was 76.2% with CWI; 75.5% without CWI; HR 0.97, 95% CI, 0.79 to 1.18
Abstractreviewer’s wording
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
10 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.
- partialReviewer 1Triple negative breast cancer patients may have worse overall survival with CWI.The subgroup analysis shows a statistically significant HR of 2.05, but the paper acknowledges the finding could be due to low numbers and is exploratory.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).
Resultsreviewer’s wording - supportedReviewers 1, 2Chest wall irradiation did not improve overall survival in intermediate-risk breast cancer patients.The primary endpoint analysis shows no significant difference in overall survival between the two arms, with a HR of 1.04 and 95% CI including 1.Evidence: Primary endpoint result: HR 1.04, 95% CI 0.82-1.30, p=0.80.
“chest wall irradiation did not improve overall survival.”
ConclusionFind in source - supportedReviewer 1Chest wall irradiation reduced chest wall recurrence.The secondary endpoint analysis shows a statistically significant reduction in chest wall recurrence with CWI, though the absolute difference is small.Evidence: Chest wall recurrence: HR 0.45, 95% CI 0.20-0.99.
“There were 29 chest wall recurrences (9 with CWI, 20 without CWI), representing <2% absolute difference; HR 0.45; 95% CI, 0.20 to 0.99.”
AbstractFind in source - supportedReviewer 1Chest wall irradiation did not improve disease-free survival or distant metastasis-free survival.Both secondary endpoints show no significant difference between arms, with HRs close to 1 and CIs including 1.Evidence: DFS HR 0.97 (0.79-1.18); DMFS HR 1.06 (0.86-1.31).
“Disease-free survival was 78.2% with CWI and 75.5% without CWI; HR 0.97; 95% CI, 0.79 to 1.18, and distant metastasis-free survival was 78.2% with CWI and 79.2% without CWI; HR 1.06; 95% CI, 0.86 to 1.31.”
AbstractFind in source - supportedReviewer 1The trial provides robust data despite lower than planned events.The paper explains that the original power calculation is no longer informative due to improved survival, and the observed survival rates are higher than expected, but the trial still provides reliable estimates with wide CIs.Evidence: Discussion: 'We consider that the original power calculation is no longer informative since breast cancer mortality has fallen considerably since SUPREMO started.'
We consider that the original power calculation is no longer informative since breast cancer mortality has fallen considerably since SUPREMO started.
Discussion ¶2reviewer’s wording - supportedReviewer 1The lack of effect on overall survival is unlikely due to inadequate radiotherapy.The paper cites the radiotherapy QA program and the observed reduction in local recurrence as evidence that radiotherapy was delivered adequately.Evidence: Discussion: 'The radiotherapy QA program and observed relative reduction in local recurrence – albeit a clinically insignificant absolute reduction of 11 patients in 10 years – provides reassurance that the lack of impact of CWI on overall survival is unlikely to be due inadequate radiotherapy.'
“The radiotherapy QA program and observed relative reduction in local recurrence – albeit a clinically insignificant absolute reduction of 11 patients in 10 years – provides reassurance that the lack of impact of CWI on overall survival is unlikely to be due inadequate radiotherapy.”
Discussion ¶4Find in source - supportedReviewer 2Chest wall irradiation reduced chest wall recurrence, but the absolute difference was small (<2%).The secondary endpoint shows a reduction in chest wall recurrence (HR 0.45, 95% CI 0.20-0.99), and the absolute difference is reported as <2%.Evidence: Secondary endpoint results: 29 chest wall recurrences (9 with CWI, 20 without CWI), HR 0.45, 95% CI 0.20-0.99.
“There were 29 chest wall recurrences (9 with CWI, 20 without CWI), representing <2% absolute difference; HR 0.45; 95% CI, 0.20 to 0.99.”
AbstractFind in source - supportedReviewer 2The trial provides robust data despite lower than planned events due to improved survival.The paper acknowledges the lower event rate and explains that the original power calculation is no longer informative due to improved survival, but argues the data are still robust.Evidence: Discussion: 'We consider that the original power calculation is no longer informative since breast cancer mortality has fallen considerably since SUPREMO started. Consequently, 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 original power calculation is no longer informative since breast cancer mortality has fallen considerably () since SUPREMO started. Consequently, 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 ¶2Find in source - supportedReviewer 2Triple-negative breast cancer patients appeared to have worse overall survival with chest wall irradiation.The subgroup analysis shows a statistically significant worse outcome for TNBC patients (HR 2.05, 95% CI 1.05-4.02), but the paper notes this could be due to low numbers.Evidence: Subgroup analysis: 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), and .”
ResultsFind in source - supportedReviewer 2The results challenge the concept that chest wall irradiation should remain a central tenet of post-mastectomy radiotherapy.The primary result shows no survival benefit, and the paper argues that the minimal local control benefit does not translate into a survival advantage, challenging the current paradigm.Evidence: Discussion: 'Our data challenge the concept that chest wall irradiation should remain a central tenet of locoregional post-mastectomy radiotherapy.'
“Our data challenge the concept that chest wall irradiation should remain a central tenet of locoregional post-mastectomy radiotherapy.”
Discussion ¶3Find in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- N/ASurrogate endpointThe primary endpoint is overall survival, a hard clinical outcome, not a surrogate.
“Primary endpoint was overall survival, with 10 years of follow-up.”
- ADEQUATEEffect sizeThe primary effect is a null result on overall survival (HR 1.04, 95% CI 0.82-1.30), with a small absolute difference in chest wall recurrence (<2%). The effect size is anchored to clinical meaningfulness by comparing to the pre-specified expected benefit and discussing the minimal impact on survival.
“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).”
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
1 finding · worst mediumRequired 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
The introduction cites the Danish and Canadian RCTs and the 2014 EBCTCG meta-analysis, noting that adjuvant systemic therapy in those trials is now considered sub-optimal. It then explains that major improvements in systemic therapy challenge the applicability of the evidence base, creating uncertainty that the SUPREMO trial aims to resolve. The limitations of prior work are explicitly addressed, and 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.”
“Adjuvant systemic therapy in these trials is now considered sub-optimal.”
“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.”
“We present a more contemporary picture of the impact of post-mastectomy radiotherapy selectively to the chest wall on overall survival in the 10-year results of the BIG 2.04 MRC/EORTC SUPREMO trial.”
Randomization was 1:1 by permuted blocks with stratification by center. The unit of randomization is the individual patient. Blinding is not explicitly described, but the primary endpoint (overall survival) is objective and unlikely to be biased. A power analysis was performed, though the sample size was revised due to slower accrual. Inclusion and exclusion criteria are detailed in the methods and supplement. Outlier handling is not explicitly discussed, but the analysis is ITT with Cox models, which is standard. The control group (no CWI) is appropriate. Independent replication is not applicable for a single pivotal trial.
“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”
“Protocol (v.27) specified a target sample size of 3500 patients to have 80% power to detect a significant difference at the 5% level under a superiority design when the five-year survival rates ± CWI were 75% and 79% with accrual over 4 years.”
“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer without distant metastases (specified as pT1-2N1; pT2N0 if also grade III and/ or LVI) and had a minimum clear margin of 1 mm, including patients undergoing immediate breast reconstruction.”
“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”
“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer without distant metastases (specified as pT1-2N1; pT2N0 if also grade III and/ or LVI) and had a minimum clear margin of 1 mm, including patients undergoing immediate breast reconstruction.”
Sex is reported (all female). Age is reported as median and quartiles, and by age groups. Tumor characteristics (histological grade, molecular subtypes, TN stage) are detailed. Demographics such as age and tumor characteristics are provided. Species/strain and housing conditions are not applicable for a human trial.
“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”
“Age (years) | 55.0 (48.0, 64.0) | 54.0 (47.0, 64.0)”
The protocol received UK ethical approval with a reference number, and equivalent approval in non-UK jurisdictions. All patients provided written informed consent. Regulatory compliance is implied through adherence to Good Clinical Practice and the statement of trial oversight.
“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 investigational product is radiotherapy, with doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions, and the clinical target volume is described. The radiotherapy quality assurance protocol is referenced. Statistical software is not explicitly named, but the methods (Cox model, Kaplan-Meier) are standard and the analysis is described in sufficient detail. No antibodies, cell lines, or other wet-lab reagents are used, so those criteria are not applicable.
“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”
“ISRCTN registration is 61145589.”
“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”
“Radiotherapy was quality assured at institute and patient level.”
The primary analysis uses Cox proportional hazards models with 95% CIs and exact p-values. Proportional hazards assumptions were checked via Schoenfeld residuals. Effect sizes are reported as hazard ratios with 95% CIs. Data presentation includes Kaplan-Meier plots and forest plots. Statistical software is not explicitly named, but the methods are standard. Mathematical plausibility checks are not applicable for time-to-event data with large N.
“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, adjusting for three geographical clusters of center (UK, Europe, other international).”
“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.”
“Proportional hazards checks were made for every covariate by Schoenfeld residuals score tests (S4.3).”
“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, adjusting for three geographical clusters of center (UK, Europe, other international). 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.”
The paper does not include an explicit data availability statement. It mentions that the trial is registered (ISRCTN 61145589) and that data management was done by the Scottish Clinical Trials Research Unit, but no repository deposit or access procedure is described. Code sharing is not mentioned. For a clinical trial, a data-sharing statement is expected, even if managed access.
“The TRANS-SUPREMO tissue archive is available for investigating prognostic and predictive biomarkers.”
Methods are comprehensive, including eligibility criteria, treatment protocols, and statistical analysis. The trial is registered with ISRCTN number 61145589. Limitations are discussed in the Discussion section. Conclusions are proportional, noting the lack of survival benefit and the context of improved systemic therapy. Funding sources (UK MRC, NIHR, etc.) are stated. A specific reporting guideline (e.g., CONSORT) is not mentioned, but the paper is well-structured.
“ISRCTN registration is 61145589.”
“Our trial has some limitations. First, SUPREMO was initiated nearly two decades ago.”
“ISRCTN registration is 61145589.”
“Funding Supported by UK MRC and NIHR, EORTC Academic Research Fund and Breast Cancer Group, Dutch Cancer Society, Cancer Australia, Breast Cancer Institute Endowment Fun”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
None found · partly checkedReferences 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.
Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.
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).
Copyediting
6 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 6 minor suggestions below.
6 copyedit issues flagged: mostly typo, consistency, clarity.
- MINORtypoAbstract, Results“hazard ratio (HR) of 1.04; 95% confidence interval [CI], 0.82 to 1.30, (p=0.80).”→ Remove the comma before the parenthesis: '...1.30 (p=0.80).'Minor punctuation.
- MINORconsistencyResults, Secondary endpoints“For disease-free survival, 388 events of breast cancer recurrence or death were noted: 192 (23.8%) with irradiation, 196 (24.5%) without irradiation. Ten-year estimated disease-free survival was 76.2% with CWI; 75.5% without CWI; HR 0.97, 95% CI, 0.79 to 1.18”→ Ensure consistency in the use of 'CWI' vs 'irradiation' throughout the results.Minor inconsistency in terminology.
- MINORclarityMethods, Statistical analysis“We report three of the most relevant pre-specified subgroup analyses– age-group, nodal status, molecular subtype, performed by estimation of strata-specific estimates and confidence intervals.”→ Change the dash to a colon or rephrase for clarity: 'We report three of the most relevant pre-specified subgroup analyses: age-group, nodal status, and molecular subtype, performed by estimation of strata-specific estimates and confidence intervals.'Punctuation and clarity.
- MINORconsistencyAbstract, Methods“Trial Reg:”→ Complete the registration number or remove the placeholder.The abstract ends with 'Trial Reg:' but no number is provided; the registration is given in the Methods.
- MINORclarityResults, Pre-planned sub-group analyses“The number of events for pN0 patients: 191 with irradiation, 211 without irradiation; for pN1 patients: 614 with irradiation, 587 without irradiation; (HR 0.82, 95% CI, 0.63 to 1.05) for pN1 relative to pN0.”→ Clarify that these are patient counts, not event counts, as the numbers (191, 211, 614, 587) are larger than the total events (295).The text says 'number of events' but the numbers are larger than the total events, likely referring to patient numbers in each subgroup.
- MINORtypoAcknowledgments“Endowment Fun”→ Change to 'Endowment Fund'.Typo in funding acknowledgment.
The published work is robust and methodologically sound; an informed reader should weigh the minor reporting gaps (data availability, blinding statement, statistical software) as limitations but not as threats to validity. No erratum is warranted based on the identified issues, though the internal contradiction in disease-free survival percentages should be clarified.
- 1.HIGHdata codeAdd a concrete data availability statement in the Methods/Oversight section specifying how to access the de-identified dataset (e.g., via the Scottish Clinical Trials Research Unit or a managed-access platform like YODA), including any conditions for access.The current statement is vague and does not provide a clear access mechanism, which is expected for a clinical trial.
- 2.HIGHdata codeProvide accession numbers or a link to the TRANS-SUPREMO tissue archive or any data repository where the data are deposited.Accession numbers enable readers to locate and reuse the data, improving transparency.
- 3.HIGHreportingResolve the internal contradiction in disease-free survival percentages: the abstract reports 78.2% with CWI while the results section reports 76.2% with CWI; correct the erroneous value.An internal contradiction in a key secondary endpoint undermines trust in the reported results.
- 4.MEDIUMreportingExplicitly state whether the trial was open-label and provide a rationale for not blinding patients and clinicians, and clarify blinding of outcome assessors.Blinding is not described, and while the primary endpoint is objective, secondary endpoints could be biased; a clear statement is needed.
- 5.MEDIUMstatisticsName the statistical software (e.g., SAS, R) and version used for the analysis in the Statistical analysis section.Identifying software is part of reproducible reporting and is currently missing.
- 6.MEDIUMreportingMention adherence to a reporting guideline (e.g., CONSORT) in the Methods section, or include a completed CONSORT checklist as supplementary material.Explicitly referencing a reporting guideline demonstrates compliance and improves completeness.
- 7.MEDIUMreportingAdd a statement about how outliers were handled in the statistical analysis, or state that no outliers were excluded.Outlier handling is not reported, and a clear statement would address a potential reviewer concern.
- 8.MEDIUMdata codeInclude a statement about code sharing, even if no custom code was used, or provide access to the analysis scripts in a public repository.Code sharing is part of data availability expectations and is currently not mentioned.
- 9.LOWcopyeditFix the typo in the Acknowledgments: change 'Endowment Fun' to 'Endowment Fund'.A typo in a funding acknowledgment is unprofessional and easily corrected.
- 10.LOWcopyeditRemove the comma before the parenthesis in the Abstract Results: change '1.30, (p=0.80)' to '1.30 (p=0.80)'.Minor punctuation error that should be corrected for clarity.
- 11.LOWcopyeditEnsure consistent use of 'CWI' vs 'irradiation' throughout the Results section.Inconsistent terminology can confuse readers.
- 12.LOWcopyeditChange the dash to a colon in the Methods Statistical analysis: 'subgroup analyses– age-group' to 'subgroup analyses: age-group'.Punctuation and clarity improvement.
- 13.LOWcopyeditComplete the trial registration number in the Abstract Methods: 'Trial Reg:' should include the ISRCTN number or be removed.An incomplete placeholder is unprofessional and should be fixed.
- 14.LOWcopyeditClarify in the Results Pre-planned sub-group analyses whether the numbers (191, 211, 614, 587) are patient counts or event counts, as they exceed the total events.The current wording is ambiguous and could mislead readers.
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.