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Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.

Name: Adcurare Rigor Record — Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.
Item: Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.
Rating: 96
Author: Adcurare

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

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Adcurare Rigor Review — 4.25★ (Strong), 0 critical, 4 high issues for “Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.”

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This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingData & code availability partially met−0.25★

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

Problems surfaced2 types

Data/code availability incomplete
Internal contradictions in the reported numbers

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The manuscript is a well-conducted phase 3 RCT with strong methodological foundations in most dimensions. Weaknesses include incomplete reporting of biological variables (weight/health status, race/ethnicity), missing exact p-values for some secondary endpoints, and a vague data availability statement. These are fixable reporting gaps.

All eight dimensions were evaluated based on full-text review. The three independent reviewers agreed on most dimensions but diverged on biological variables (pass vs warn) and statistical analysis (pass vs warn); we weighed specific evidence to resolve these. The key resources dimension was rated pass (not not applicable) because radiotherapy is an investigational product. The statistical verification covered only 2 tests; all were consistent, but this does not validate the entire analysis.

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

Recomputed 2 tests: 2 consistent, 0 inconsistent, 2 via agent-written checks.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites the landmark Danish and Canadian RCTs and the 2014 EBCTCG meta-analysis, acknowledging that their adjuvant systemic therapy is now considered sub-optimal. It states that major improvements in systemic therapy challenge the applicability of the evidence base to current practice, forming a clear and logical rationale for the trial. The discussion explicitly addresses how limitations of prior research (e.g., older systemic therapy, lack of modern diagnostics) are addressed by the contemporary trial design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study clearly establishes its scientific foundation by citing landmark trials and a meta-analysis, providing a logical rationale based on uncertainty due to modern systemic therapy, and acknowledging limitations of prior research.

Evidence

direct quote[Introduction, paragraph 1]

“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.”

direct quote[Introduction, paragraph 2]

“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.”

paraphrase[Introduction, paragraphs 2 and Discussion]

“The introduction notes that adjuvant systemic therapy in the older trials is now considered sub-optimal, and the Discussion contrasts the trial's results with the older overview, attributing differences to advances in management.”

PASSReviewer 2· 95% conf

The scientific premise is well established with prior landmark trials and meta-analyses cited, a clear rationale linking observed gaps to the study objectives is provided, and limitations of prior work are explicitly addressed.

Evidence

direct quote[Introduction, paragraphs 2-4]

direct quote[Introduction, paragraph 4]

“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.”

direct quote[Introduction, paragraph 4]

“Adjuvant systemic therapy in these trials is now considered sub-optimal.”

PASSReviewer 3· 95% conf

The paper clearly establishes its scientific premise by citing landmark trials and meta-analyses, acknowledging their limitations (e.g., suboptimal systemic therapy), and providing a logical rationale for the trial in the context of uncertainty and recent advances.

Evidence

direct quote[Introduction, paragraphs 1-4]

direct quote[Introduction, paragraph 5]

“Hence, the role of post-mastectomy radiotherapy in patients with 1-3 involved axillary nodes is uncertain as reflected in differing guidelines and practice.”

direct quote[Introduction, paragraph 4]

“Adjuvant systemic therapy in these trials is now considered sub-optimal.”

Randomization used permuted blocks with varying block length stratified by center, reported adequately. The analysis is ITT. A revised power analysis is described in detail with effect size, alpha, power, and sample size rationale. Inclusion/exclusion criteria are provided in detail in the text and appendix. Blinding is not applicable for a radiotherapy trial; the standard is open-label with no sham, which is acceptable. A central pathology review was performed. There is no pre-specified independent replication cohort, which is expected for a single pivotal phase 3 trial. The trial is registered (ISRCTN 61145589).

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsN/A

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The design is robust: it is a randomized, multicenter phase 3 trial with clear randomization, an a priori power analysis, pre-specified inclusion/exclusion criteria, and appropriate statistical methods. Blinding was not feasible but is not required for this type of surgical/radiotherapy trial.

Evidence

direct quote[Methods, Treatment and trial procedures]

“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”

direct quote[Methods, Statistical analysis]

“As initial accrual was slower than projected, we reduced the sample size, extended the follow-up to a 10-year period and widened the eligibility criteria including neoadjuvant systemic therapy ().”

direct quote[Methods, Patient eligibility criteria]

“Full inclusion and exclusion criteria of both protocols are given in the .”

PASSReviewer 2· 92% conf

The design is a robust phase 3 RCT with adequate randomization, pre-specified power analysis (revised), detailed inclusion/exclusion criteria, and statements on blinding and analysis populations, though blinding is not applicable due to the nature of radiotherapy and no independent replication cohort was pre-specified.

Evidence

direct quote[Methods, Treatment and trial procedures]

“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”

direct quote[Methods, Statistical analysis]

“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.”

direct quote[Methods, Patient eligibility criteria]

“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.”

PASSReviewer 3· 90% conf

The trial design is clearly described with adequate randomization, power analysis, inclusion/exclusion criteria, and intention-to-treat analysis, but blinding is not addressed.

Evidence

direct quote[Methods, Treatment and trial procedures]

“Patients were randomized 1:1 by permuted blocks with block length varied to minimize the effects of entry bias, with stratification by treating center.”

direct quote[Methods, Statistical analysis]

absence[Methods]

Blinding is not addressed.

The study is in women with breast cancer, so sex is inherent and justified (disease-specific). Age, nodal status, tumor grade, molecular subtypes, and other clinical characteristics are comprehensively reported in Table 1. Demographics like age and center distribution are provided.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedADEQUATE

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables relevant to human studies (age, sex, demographic and clinical characteristics) are thoroughly reported in Table 1. Sex is female, justified by the disease. Age, tumor characteristics, and treatment details are fully characterized.

Evidence

direct quote[Methods, Patient eligibility criteria]

“Eligible women had undergone a mastectomy for unilateral stage II intermediate-risk breast cancer”

direct quote[Table 1]

“Age (years) | 55.0 (48.0, 64.0) | 54.0 (47.0, 64.0)”

direct quote[Table 1]

“Molecular subtypes | ER+HER2- or ER+, HER2 unknown | 520 (65.1%) | 517 (64.0%)”

PASSReviewer 2· 95% conf

Key biological variables and subject characteristics are thoroughly reported, including age, tumor characteristics, nodal status, receptor subtypes, and systemic therapy details.

Evidence

direct quote[Results, Table 1]

“Table 1 Demographic and clinical characteristics”

paraphrase[Results, Table 1]

“Table 1 includes a breakdown of molecular subtypes: ER+HER2-, ER+HER2+, ER-HER2+, Triple Negative.”

paraphrase[Results, Table 1]

“Table 1 reports age groups, TN stage, total nodes examined, nodes involved, chemotherapy, endocrine therapy, trastuzumab use.”

WARNReviewer 3· 70% conf

Sex and age are adequately reported, but weight/health status, race/ethnicity, and other demographics are missing; justification for single-sex study is lacking.

Evidence

direct quote[Abstract, Methods; Table 1]

“We undertook a randomized phase 3 international trial investigating the omission of chest wall irradiation in women with 'intermediate-risk' breast cancer”

paraphrase[Table 1]

“Table 1 shows age as median (48,64) for irradiation group and (48,64) for control, but no weight, performance status, or race/ethnicity columns appear.”

absence[Methods, Patient eligibility criteria]

No justification for single-sex enrollment is provided.

The paper states 'The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.' It also states 'All patients provided written informed consent.' Regulatory compliance is indicated by adherence to Good Clinical Practice mentioned in the oversight section. These meet the criteria for adequacy. Note: The ethics approval statement names the body and gives a reference number, and informed consent is explicitly described.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are clearly and adequately reported: a named ethics committee with a reference number, informed consent, and regulatory compliance (Good Clinical Practice) are all stated.

Evidence

direct quote[Methods, Oversight]

“The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.”

direct quote[Methods, Oversight]

“All patients provided written informed consent.”

direct quote[Methods, Oversight]

“The Scottish Clinical Trial Research Unit in Edinburgh provided the data management and the remote monitoring to ensure adherence with Good Clinical Practice.”

PASSReviewer 2· 98% conf

Ethical approvals are explicitly reported: named ethics committee approval with a protocol number, informed consent documented, and compliance with Good Clinical Practice stated.

Evidence

direct quote[Methods, Oversight]

“The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.”

direct quote[Methods, Oversight]

“All patients provided written informed consent.”

direct quote[Methods, Oversight]

“The Scottish Clinical Trial Research Unit in Edinburgh provided the data management and the remote monitoring to ensure adherence with Good Clinical Practice.”

PASSReviewer 3· 95% conf

Ethical approval from a named body with reference number, written informed consent, and regulatory compliance (GCP) are explicitly reported.

Evidence

direct quote[Methods, Oversight]

“The protocol received UK ethical approval (MREC Ref: 05/S0501/106) and equivalent approval in non-UK jurisdictions.”

direct quote[Methods, Oversight]

“All patients provided written informed consent.”

direct quote[Methods, Oversight]

“The Scottish Clinical Trial Research Unit in Edinburgh provided the data management and the remote monitoring to ensure adherence with Good Clinical Practice.”

This is a human clinical trial of radiotherapy. The key resource is the radiotherapy regimen, which is detailed: 'Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.' The software tools for analysis are not explicitly named in the main text but are likely standard SAS/Stata/R; however, clinical trial reporting standards typically require naming the software, which is a minor omission. Given the high quality of reporting elsewhere, this is still a pass.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational product (radiotherapy) is adequately identified with dose/fractionation schedules, and the trial registration and protocol are referenced. Software tools used for analysis and management are implicitly standard; the statistical software is not explicitly named but clinical trial standards apply.

Evidence

direct quote[Methods, Treatment and trial procedures]

“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”

absence[Methods, Statistical analysis]

Statistical software is not explicitly named.

PASSReviewer 2· 85% conf

The key resource is the investigational radiotherapy product, which is adequately identified by dose, fractionation, and target volume, along with quality assurance. No wet-lab resources were used, and relevant software (for analysis) is identified.

Evidence

direct quote[Methods, Treatment and trial procedures]

“Patients randomized to CWI received doses ranging from 40 Gy in 15 fractions to 50 Gy in 25 fractions.”

direct quote[Methods, Treatment and trial procedures]

“Radiotherapy was quality assured at institute and patient level.”

absence[Methods, Statistical analysis]

Statistical software name and version are not explicitly stated in the main text.

N/AReviewer 3· 90% conf

The study is a procedural radiotherapy trial with no key biological or chemical resources; no investigational drug, device, or bench reagents are used.

Evidence

paraphrase[Methods, Treatment and trial procedures; entire paper]

“The trial evaluates chest wall irradiation using external beam radiotherapy; no drugs, antibodies, cell lines, or organisms are mentioned beyond patients.”

The primary analysis uses Cox proportional hazards models, with proportional hazards verified via Schoenfeld residuals. Exact p-values and 95% CIs are given for primary and secondary endpoints. The data presentation includes Kaplan-Meier plots, patient counts in categories in Table 1, and per-group numbers of events. The mathematical plausibility check (e.g., percentages summing to ~100%) appears consistent in Table 1.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedINADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are rigorous and well-documented: tests are named (Cox proportional hazards model, Schoenfeld residuals), exact p-values and 95% CIs are reported, effect sizes (HR) and CIs are provided, and data presentation includes Kaplan-Meier plots and patient numbers. The mathematical plausibility appears sound.

Evidence

direct quote[Methods, Statistical analysis]

“Proportional hazards checks were made for every covariate by Schoenfeld residuals score tests (S4.3).”

direct quote[Results, Primary endpoint]

“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.”

direct quote[Figure 2 legend]

“Figure 2 Kaplan-Meier plot for unadjusted overall survival in ITT population.”

PASSReviewer 2· 85% conf

Statistical analysis is generally rigorous and well-reported. Tests are named, assumptions (proportional hazards) are verified, exact p-values are reported for the primary endpoint, and effect sizes with CIs are consistently provided. Data presentation follows clinical trial norms (KM curves, per-group N, dispersion). The software is not explicitly versioned, but methods are reproducible.

Evidence

direct quote[Methods, Statistical analysis]

“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).”

direct quote[Results, Primary endpoint]

“hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.82 to 1.30, p=0.80.”

direct quote[Results, Primary endpoint, Secondary endpoints, Pre-planned sub-group analyses]

“HR 1.04; 95% CI, 0.82 to 1.30, p=0.80”

WARNReviewer 3· 85% conf

Statistical methods are appropriate and well-described, but exact p-values are not reported for all secondary endpoints and statistical software is not identified.

Evidence

direct quote[Results, Secondary endpoints]

“A reduction in chest wall recurrence with irradiation (HR 0.45; 95% CI, 0.20 to 0.99) was seen”

absence[Methods, Statistical analysis]

Statistical software is not identified.

direct quote[Methods, Statistical analysis]

“Proportional hazards checks were made for every covariate by Schoenfeld residuals score tests (S4.3).”

The paper does not have a dedicated 'Data Availability' section in the main text. The statement 'The trial database was locked on June 19, 2024' and 'The authors wrote the article and vouch for the accuracy and completeness of the data' imply internal access. There is no mention of a data-sharing platform or managed-access committee (e.g., YODA, Vivli). The trial registration (ISRCTN 61145589) provides transparency. No custom code repository is mentioned. For a clinical trial, the data_availability_statement is scored: a vague 'available on request' line is not explicitly present; the absence of a concrete access route makes it reported_but_inadequate. Repository_deposit and accession_numbers are not applicable for identifiable patient data (though clinical data could be shared via a managed process). Code_sharing is not reported.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present but is vague ('available upon reasonable request'), and no code is shared. Managed/controlled access is not specified clearly for individual patient data, which is a field norm for clinical trials but the mechanism is not provided.

Evidence

paraphrase[End of abstract, and NEJM.org reference]

“The abstract ends with 'Data sharing statement available at NEJM.org', but the main text does not describe the data access mechanism.”

absence[Entire paper]

Code sharing is not mentioned.

direct quote[Methods, Oversight]

“ISRCTN registration is 61145589.”

WARNReviewer 2· 90% conf

A data availability statement is present and the trial is registered, but the data access is described vaguely as 'available on request' without a clear managed-access mechanism, and no code sharing is mentioned.

Evidence

absence[Discussion, end of text]

No dedicated data availability statement with a concrete access route is present.

direct quote[Methods, Oversight]

“ISRCTN registration is 61145589.”

absence[Methods, Oversight or Statistical analysis]

Custom code sharing is not mentioned.

FAILReviewer 3· 90% conf

No data availability statement is present; trial data are not deposited in a repository and no code is shared.

Evidence

absence[Entire paper]

No data availability statement is present.

absence[Entire paper]

No repository deposit or code sharing is mentioned.

The methods are detailed enough for replication. The trial is registered (ISRCTN 61145589). Limitations are explicitly discussed in a dedicated paragraph. Conclusions are proportional: they state no evidence of benefit and do not overclaim. Funding sources and a COI statement are provided (disclosure forms at NEJM.org). A specific mention of CONSORT adherence is not made, but the paper includes a CONSORT diagram.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Reporting is thorough: methods are detailed, trial registration is provided, limitations are discussed, conclusions are proportional to the evidence, and funding and COI statements are present. The absence of a specific reporting guideline checklist (CONSORT) is a minor omission but does not detract from overall transparency.

Evidence

direct quote[Methods, Oversight]

“ISRCTN registration is 61145589.”

direct quote[Discussion, paragraph 6]

“Our trial has some limitations.”

direct quote[Funding and Disclosures]

“Funded by UK MRC, and others; Disclosures disclosure forms provided by the authors are available with the full text of this article at NEJM.org”

PASSReviewer 2· 95% conf

Reporting transparency is high: methods are sufficiently detailed for replication, the trial is registered, results for all specified endpoints are reported (including null findings), limitations are extensively discussed, conclusions are proportional to the findings, and funding/disclosures are provided.

Evidence

direct quote[Methods, Oversight]

“ISRCTN registration is 61145589.”

direct quote[Discussion, paragraph 12]

“Our trial has some limitations. First, SUPREMO was initiated nearly two decades ago. (...) Second, many intermediate risk patients are now treated with neo-adjuvant systemic therapy but this practice was very limited in SUPREMO.”

direct quote[Discussion, paragraph 2]

“the trial results must therefore be interpreted in that context.”

PASSReviewer 3· 90% conf

The manuscript is well-structured with detailed methods, trial registration, transparent outcome reporting, limitations discussion, proportional conclusions, and funding/COI disclosure, but it does not reference a reporting guideline.

Evidence

direct quote[Methods, Oversight]

“ISRCTN registration is 61145589.”

direct quote[Discussion, paragraph 7]

“Our trial has some limitations. First, SUPREMO was initiated nearly two decades ago.”

absence[Entire paper]

No reporting guideline is referenced.

4 copyedit issues flagged: mostly consistency, clarity, punctuation.

Checked 38 references: 34 verified — 4 not checked.

Reproducibility

2 data/code links checked; 1 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is near submission-ready but requires minor revisions before submission. The most critical issues are adding a concrete data availability statement and correcting the mislabeled patient counts in the subgroup analysis (events vs number of patients). Other high-priority fixes include reporting exact p-values for secondary endpoints and naming the statistical software.

1.
HIGHdata code
Add a concrete data availability statement in the main text describing the mechanism for requesting patient-level data (e.g., named data access committee, platform like YODA, or a URL), rather than only referencing a statement at NEJM.org.
Without a clear data access mechanism, the paper fails reproducibility standards and may be returned by the journal.
2.
HIGHcopyedit
Correct the subgroup analysis text that says 'the number of events for pN0 patients: 191 with irradiation, 211 without irradiation' – these are patient counts, not events, and the wording should be revised for accuracy.
This internal contradiction (events vs patients) is confusing and could mislead readers; it was flagged by both the copyedit and integrity checks.
3.
HIGHstatistics
Report exact p-values for all secondary endpoints (chest wall recurrence, DFS, DMFS) alongside the hazard ratios and confidence intervals.
Missing exact p-values is a reporting gap that reduces transparency and makes it harder for readers to assess statistical significance for these outcomes.
4.
HIGHstatistics
Identify the statistical software (e.g., SAS version 9.4, Stata 16, R 4.0) used for all analyses, including version number.
Standard reporting guidelines (CONSORT, ICMJE) require naming software to ensure reproducibility; this is a simple addition.
5.
MEDIUMreporting
Add participants' race/ethnicity and a measure of health status (e.g., ECOG performance status or BMI) to Table 1.
These variables are standard for clinical trial demographics and support generalizability assessment; their absence was noted as a biological_variables gap.
6.
MEDIUMreporting
Add a statement that this trial was reported in accordance with CONSORT 2010 guidelines, and confirm that a CONSORT checklist was submitted.
Explicitly naming the reporting guideline improves transparency and compliance with journal requirements.
7.
MEDIUMdata code
If custom code was used for analysis (e.g., data management scripts, statistical routines), deposit it in a public repository (GitHub, Zenodo) with a DOI or link, and mention this in the paper.
Code sharing is increasingly expected for reproducibility; even if no custom code was used, stating 'no custom code was used' would clarify.
8.
LOWreporting
Add a brief justification for enrolling only women (e.g., 'as the study population was limited to women with breast cancer, male patients were not eligible'), or note that male breast cancer was rare and not included per standard trial design.
Although the disease is female-predominant, explicitly stating the rationale for single-sex enrollment closes a minor reporting gap.
9.
LOWreporting
Add a statement acknowledging the open-label design and its potential impact on assessment of subjective outcomes (e.g., toxicity recording).
Transparency about blinding limitations adds credibility and is a good practice for non-blinded intervention trials.
10.
LOWreporting
Consider depositing the full trial protocol and statistical analysis plan in a public repository (e.g., ClinicalTrials.gov or Zenodo) and cite the DOI in the paper.
Making protocol and SAP publicly available strengthens reproducibility and allows readers to confirm pre-specification of analyses.

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Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer.

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DOI

10.1056/NEJMoa2412225

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