Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

Name: Kaimen Rigor review — Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.
Item: Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.
Rating: 96
Author: Alpha1

Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D, SURPASS-CVOT Investigators

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Kaimen Rigor review — 4.25★ (Strong), 0 critical, 2 high issues for “Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

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DOI

10.1056/NEJMoa2505928

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

Paper source

Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

Read full text

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen 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: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 22 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit2 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 randomized controlled trial with strong methodological rigor across most dimensions. The primary weakness is the vague data availability statement, which does not specify the access mechanism or repository.

Both reviewers agreed on study type (interventional). All eight dimensions were applicable; no dimensions were excluded as not applicable. The reviewers' assessments were highly concordant, with minor divergence on the regulatory compliance sub-criterion within ethical approvals, which did not affect the overall status.

Numerical inconsistencies

1 finding · worst low

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

Internal contradictions in the reported numbersAssessed

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

None found

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.

Checked — nothing surfaced.

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

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

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 prior trials showing GLP-1 receptor agonists reduce cardiovascular events and that tirzepatide improves metabolic risk factors, but notes the lack of a dedicated cardiovascular outcomes trial. The rationale for using dulaglutide as an active comparator is explicitly stated, and the noninferiority margin is justified. Limitations of prior work (small, short-duration pooled analyses) are acknowledged in the Discussion.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a clear scientific premise by citing prior trials of GLP-1 receptor agonists and tirzepatide, and provides a logical rationale for the noninferiority design.

Evidence

“Clinical trials have shown that glucagon-like peptide-1 (GLP-1) receptor agonists reduce the incidence of major adverse cardiovascular events among patients with high cardiovascular risk and type 2 diabetes, 2-7 chronic kidney disease, 8,9 or obesity. 10”

Introduction ¶1Find in source

“The established role of GLP-1 receptor agonists in the management of type 2 diabetes in patients with high cardiovascular risk 2-7 precluded direct comparison of tirzepatide with a placebo control in a large, long-term clinical trial.”

Introduction ¶2Find in source

“Although a pooled analysis of previous trials of tirzepatide has examined the effect of tirzepatide on cardiovascular events, 28 those trials were small and short in duration.”

Discussion ¶2Find in source

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior trials of GLP-1 receptor agonists and tirzepatide, and logically justifies the need for a cardiovascular outcomes trial.

Evidence

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 1]

“However, data from a randomized, clinical trial of the effect of tirzepatide on cardiovascular outcomes have been lacking.”

“Although a pooled analysis of previous trials of tirzepatide has examined the effect of tirzepatide on cardiovascular events, 28 those trials were small and short in duration.”

Discussion ¶1Find in source

Randomization method (1:1 ratio, stratified by country and SGLT2 inhibitor use) is described, though the specific randomization algorithm is not detailed. Blinding is described (double-blind, sham dose-escalation). Power analysis is reported (1615 events for 90% power). Inclusion/exclusion criteria are detailed. Outlier handling is addressed via the modified intention-to-treat population and multiple imputation for missing data. Controls are inherent in the active comparator design. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

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: double-blind, randomized, active-controlled, with a prespecified noninferiority margin, power calculation, and clear inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Trial Regimen]

“Eligible patients were randomly assigned in a 1:1 ratio to receive weekly subcutaneous injections of tirzepatide at a dose adjusted up to 15 mg or dulaglutide at a dose of 1.5 mg. Randomization was stratified according to country and the use of sodium–glucose cotransporter 2 (SGLT2) inhibitors at baseline.”

paraphrase[Methods, Randomization and Trial Regimen]

“Because the dose of dulaglutide remained at 1.5 mg throughout the trial, a sham dose-escalation scheme was used to maintain trial blinding.”

paraphrase[Methods, Statistical Analysis]

“We calculated that a minimum of 1615 primary end-point events would provide the trial with 90% power to determine the noninferiority of tirzepatide to dulaglutide (with a 10.5% lower risk of a primary end-point event with tirzepatide) and the superiority of tirzepatide to dulaglutide (with a 15% lower risk of a primary end-point event with tirzepatide) at a two-sided alpha level of 0.05.”

PASSReviewer 2· 95% conf

The trial design is rigorous: randomized, double-blind, active-comparator-controlled, with a prespecified noninferiority margin, power calculation, and clear inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Trial Regimen]

“Because the dose of dulaglutide remained at 1.5 mg throughout the trial, a sham dose-escalation scheme was used to maintain trial blinding.”

paraphrase[Methods, Statistical Analysis]

Sex is reported (29.0% women overall; Table 1 shows 28.7% and 29.3% in each group). Age, BMI, glycated hemoglobin, duration of diabetes, and comorbidities are reported. Demographics include race and ethnicity. Since both sexes are enrolled, sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial.

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· 95% conf

Demographic and clinical characteristics are comprehensively reported, including sex, age, race, and comorbidities.

Evidence

“29.0% were women”

AbstractFind in source

paraphrase[Results, Randomization, Patient Characteristics, and Follow-up]

“The mean (±SD) age of the patients was 64.1±8.8 years, 29.0% were women, the mean BMI was 32.6±5.5, 65.0% of the patients had coronary artery disease, 19.2% had a history of stroke, 25.3% had peripheral artery disease, 20.3% had a history of heart failure, and the mean duration of diabetes was 14.7±8.8 years.”

“White race — no./total no. (%)† 5299/6501 (81.5) 5282/6492 (81.4)”

Table 1Find in source

PASSReviewer 2· 95% conf

Demographic and clinical characteristics are thoroughly reported, including age, sex, race, and key cardiovascular risk factors.

Evidence

“The mean (±SD) age of the patients was 64.1±8.8 years, 29.0% were women”

AbstractFind in source

“White race — no./total no. (%)† 5299/6501 (81.5) 5282/6492 (81.4)”

Table 1Find in source

The protocol was approved by the ethics committee at each participating site, and all patients provided written informed consent. The trial is registered (NCT04255433). Regulatory compliance is implied by the trial being conducted under standard clinical trial regulations, though not explicitly named.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethics approval and informed consent are reported, and the trial is registered.

Evidence

paraphrase[Methods, Trial Organization and Oversight]

“The protocol was approved by the ethics committee at each participating site.”

paraphrase[Methods, Trial Population]

“All the patients provided written informed consent.”

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

PASSReviewer 2· 90% conf

Ethics approval and informed consent are adequately reported.

Evidence

paraphrase[Methods, Trial Organization and Oversight]

“The protocol was approved by the ethics committee at each participating site.”

paraphrase[Methods, Trial Population]

“All the patients provided written informed consent.”

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

Tirzepatide and dulaglutide are named with dosing regimens. The manufacturer (Eli Lilly) is implied as sponsor. Statistical software (SAS 9.4, RStudio 4.4.2) is identified. No antibodies, cell lines, or mycoplasma testing are applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (tirzepatide and dulaglutide) are identified with doses and regimen, and statistical software is identified.

Evidence

“Eligible patients were randomly assigned in a 1:1 ratio to receive weekly subcutaneous injections of tirzepatide at a dose adjusted up to 15 mg or dulaglutide at a dose of 1.5 mg.”

MethodsFind in source

“The statistical analyses were performed with SAS software, version 9.4 or higher (SAS Institute), and RStudio software, version 4.4.2 (Posit).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (tirzepatide and dulaglutide) are identified with doses and regimen; statistical software is identified.

Evidence

“Eligible patients were randomly assigned in a 1:1 ratio to receive weekly subcutaneous injections of tirzepatide at a dose adjusted up to 15 mg or dulaglutide at a dose of 1.5 mg.”

MethodsFind in source

“The statistical analyses were performed with SAS software, version 9.4 or higher (SAS Institute), and RStudio software, version 4.4.2 (Posit).”

Statistical analysisFind in source

Tests are named (Cox proportional-hazards, ANCOVA, Fine-Gray). Assumptions are verified (proportionality assessed). Exact p-values are reported for the primary endpoint. Effect sizes with CIs are reported throughout. Software is identified. Data presentation follows clinical trial conventions (Kaplan-Meier curves, forest plots, per-group n). Mathematical plausibility is not applicable for large-N continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

paraphrase[Methods, Statistical Analysis]

“The primary efficacy end point and the secondary end points that were assessed in time-to-clinical-event analyses were analyzed with Cox proportional-hazards models with treatment as the factor of interest and stratification according to SGLT2 inhibitor use at baseline.”

“P = 0.003 for noninferiority; P = 0.09 for superiority”

ResultsFind in source

paraphrase[Results, Efficacy End Points]

“hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01”

PASSReviewer 2· 90% conf

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

Evidence

“P = 0.003 for noninferiority; P = 0.09 for superiority”

AbstractFind in source

paraphrase[Abstract, Results]

“hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01”

paraphrase[Methods, Statistical Analysis]

“Proportionality of hazards assumptions was assessed within each stratum on the basis of SGLT2 inhibitor use at baseline, Schoenfeld residual plots, and a Kolmogorov-type supremum test.”

The paper states 'A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.' This is vague and does not specify the access mechanism. No repository deposit or accession numbers are mentioned. Code sharing is not applicable as no bespoke code is described.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is mentioned but not detailed in the provided text; no repository or accession numbers are given.

Evidence

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.”

End of article, before Author Informati…Find in source

WARNReviewer 2· 80% conf

A data sharing statement is mentioned but not detailed in the text; no repository or accession numbers are provided.

Evidence

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.”

End of article, before Author Informati…Find in source

The trial is registered (NCT04255433). Methods are comprehensive. Limitations are explicitly discussed (no placebo, lack of diversity, SGLT2 imbalance). Conclusions are appropriately cautious, noting the exploratory nature of secondary findings. Funding and COI disclosures are provided.

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 trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

paraphrase[Discussion, paragraph 5]

“Our trial has limitations. The trial did not include a placebo group because the role of GLP-1 receptor agonists in the treatment of patients with diabetes and cardiovascular risk had been established.”

“Supported by Eli Lilly. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

End of articleFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

paraphrase[Discussion, paragraph 4]

“Supported by Eli Lilly. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

End of articleFind in source

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

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 31 references by DOI: 1 verified — 30 no DOI (shown, not verified).

Copyediting

2 minor

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

No major wording or formatting errors. 2 minor suggestions below.

2 copyedit issues flagged: mostly typo, consistency.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is robust and well-reported. An informed reader should note the vague data sharing statement as a limitation for reproducibility; the authors should consider issuing a correction or supplement with a concrete data access plan. No other issues warrant an erratum or re-analysis.

1.
HIGHdata code
Replace the vague data sharing statement with a concrete description of the data access mechanism, including the repository name (e.g., Vivli, YODA) or data access committee, conditions, and timeline.
The current statement is insufficient for reproducibility and does not meet journal standards for data availability.
2.
HIGHreporting
Add an explicit statement about adherence to the CONSORT reporting guideline in the Methods or a separate section, and mention that the checklist is available as supplementary material.
Explicit reporting guideline adherence is expected for clinical trials and is currently missing.
3.
MEDIUMdata code
Consider providing a link to the full protocol and statistical analysis plan in the data availability statement, as they are currently only mentioned as available with the full text.
Access to the full protocol and SAP enhances transparency and reproducibility.
4.
MEDIUMdata code
If any bespoke analysis code was used beyond standard SAS/R functions, share it in a public repository (e.g., GitHub) with a DOI.
Code sharing further supports reproducibility, even if the code is standard.
5.
LOWcopyedit
Correct the typo 'eligibile' to 'eligible' in the Results section.
Minor typographical error that should be corrected for clarity.
6.
LOWreporting
Clarify the data sharing statement in the main text to include the URL or platform where the data sharing statement can be accessed, to avoid ambiguity.
The current reference to 'at NEJM.org' is vague; a direct link would be more helpful.

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Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

Read full text

DOI

10.1056/NEJMoa2505928

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Record fingerprint

3f0403f2c727228405afa050e626b36c8f6462c26023b55c6393f114743cbe18

Verify via API

Issued Aug 15, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen 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: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 22 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit2 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

None found

Checked — nothing surfaced.

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

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

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 addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a clear scientific premise by citing prior trials of GLP-1 receptor agonists and tirzepatide, and provides a logical rationale for the noninferiority design.

Evidence

Introduction ¶1Find in source

Introduction ¶2Find in source

“Although a pooled analysis of previous trials of tirzepatide has examined the effect of tirzepatide on cardiovascular events, 28 those trials were small and short in duration.”

Discussion ¶2Find in source

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior trials of GLP-1 receptor agonists and tirzepatide, and logically justifies the need for a cardiovascular outcomes trial.

Evidence

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 1]

“However, data from a randomized, clinical trial of the effect of tirzepatide on cardiovascular outcomes have been lacking.”

“Although a pooled analysis of previous trials of tirzepatide has examined the effect of tirzepatide on cardiovascular events, 28 those trials were small and short in duration.”

Discussion ¶1Find in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

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: double-blind, randomized, active-controlled, with a prespecified noninferiority margin, power calculation, and clear inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Trial Regimen]

“Because the dose of dulaglutide remained at 1.5 mg throughout the trial, a sham dose-escalation scheme was used to maintain trial blinding.”

paraphrase[Methods, Statistical Analysis]

PASSReviewer 2· 95% conf

The trial design is rigorous: randomized, double-blind, active-comparator-controlled, with a prespecified noninferiority margin, power calculation, and clear inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Trial Regimen]

“Because the dose of dulaglutide remained at 1.5 mg throughout the trial, a sham dose-escalation scheme was used to maintain trial blinding.”

paraphrase[Methods, Statistical Analysis]

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· 95% conf

Demographic and clinical characteristics are comprehensively reported, including sex, age, race, and comorbidities.

Evidence

“29.0% were women”

AbstractFind in source

paraphrase[Results, Randomization, Patient Characteristics, and Follow-up]

“White race — no./total no. (%)† 5299/6501 (81.5) 5282/6492 (81.4)”

Table 1Find in source

PASSReviewer 2· 95% conf

Demographic and clinical characteristics are thoroughly reported, including age, sex, race, and key cardiovascular risk factors.

Evidence

“The mean (±SD) age of the patients was 64.1±8.8 years, 29.0% were women”

AbstractFind in source

“White race — no./total no. (%)† 5299/6501 (81.5) 5282/6492 (81.4)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethics approval and informed consent are reported, and the trial is registered.

Evidence

paraphrase[Methods, Trial Organization and Oversight]

“The protocol was approved by the ethics committee at each participating site.”

paraphrase[Methods, Trial Population]

“All the patients provided written informed consent.”

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

PASSReviewer 2· 90% conf

Ethics approval and informed consent are adequately reported.

Evidence

paraphrase[Methods, Trial Organization and Oversight]

“The protocol was approved by the ethics committee at each participating site.”

paraphrase[Methods, Trial Population]

“All the patients provided written informed consent.”

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (tirzepatide and dulaglutide) are identified with doses and regimen, and statistical software is identified.

Evidence

“Eligible patients were randomly assigned in a 1:1 ratio to receive weekly subcutaneous injections of tirzepatide at a dose adjusted up to 15 mg or dulaglutide at a dose of 1.5 mg.”

MethodsFind in source

“The statistical analyses were performed with SAS software, version 9.4 or higher (SAS Institute), and RStudio software, version 4.4.2 (Posit).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (tirzepatide and dulaglutide) are identified with doses and regimen; statistical software is identified.

Evidence

“Eligible patients were randomly assigned in a 1:1 ratio to receive weekly subcutaneous injections of tirzepatide at a dose adjusted up to 15 mg or dulaglutide at a dose of 1.5 mg.”

MethodsFind in source

“The statistical analyses were performed with SAS software, version 9.4 or higher (SAS Institute), and RStudio software, version 4.4.2 (Posit).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

paraphrase[Methods, Statistical Analysis]

“P = 0.003 for noninferiority; P = 0.09 for superiority”

ResultsFind in source

paraphrase[Results, Efficacy End Points]

“hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01”

PASSReviewer 2· 90% conf

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

Evidence

“P = 0.003 for noninferiority; P = 0.09 for superiority”

AbstractFind in source

paraphrase[Abstract, Results]

“hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01”

paraphrase[Methods, Statistical Analysis]

“Proportionality of hazards assumptions was assessed within each stratum on the basis of SGLT2 inhibitor use at baseline, Schoenfeld residual plots, and a Kolmogorov-type supremum test.”

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is mentioned but not detailed in the provided text; no repository or accession numbers are given.

Evidence

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.”

End of article, before Author Informati…Find in source

WARNReviewer 2· 80% conf

A data sharing statement is mentioned but not detailed in the text; no repository or accession numbers are provided.

Evidence

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.”

End of article, before Author Informati…Find 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 trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

paraphrase[Discussion, paragraph 5]

“Supported by Eli Lilly. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

End of articleFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“SURPASS-CVOT ClinicalTrials.gov number, NCT04255433.”

ConclusionFind in source

paraphrase[Discussion, paragraph 4]

“Supported by Eli Lilly. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

End of articleFind in source

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

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 31 references by DOI: 1 verified — 30 no DOI (shown, not verified).

Copyediting

2 minor

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

No major wording or formatting errors. 2 minor suggestions below.

2 copyedit issues flagged: mostly typo, consistency.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Replace the vague data sharing statement with a concrete description of the data access mechanism, including the repository name (e.g., Vivli, YODA) or data access committee, conditions, and timeline.
The current statement is insufficient for reproducibility and does not meet journal standards for data availability.
2.
HIGHreporting
Add an explicit statement about adherence to the CONSORT reporting guideline in the Methods or a separate section, and mention that the checklist is available as supplementary material.
Explicit reporting guideline adherence is expected for clinical trials and is currently missing.
3.
MEDIUMdata code
Consider providing a link to the full protocol and statistical analysis plan in the data availability statement, as they are currently only mentioned as available with the full text.
Access to the full protocol and SAP enhances transparency and reproducibility.
4.
MEDIUMdata code
If any bespoke analysis code was used beyond standard SAS/R functions, share it in a public repository (e.g., GitHub) with a DOI.
Code sharing further supports reproducibility, even if the code is standard.
5.
LOWcopyedit
Correct the typo 'eligibile' to 'eligible' in the Results section.
Minor typographical error that should be corrected for clarity.
6.
LOWreporting
Clarify the data sharing statement in the main text to include the URL or platform where the data sharing statement can be accessed, to avoid ambiguity.
The current reference to 'at NEJM.org' is vague; a direct link would be more helpful.

Full text (44,037 chars)Analyzed: Aug 15, 2026