Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

Name: Kaimen Rigor review — Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.
Item: Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.
Rating: 96
Author: Alpha1

Vazquez MA, Oliver G, Amarasingham R, Sundaram V, Chan K, Ahn C, Zhang S, Bickel P, Parikh SM, Wells B, Miller RT, Hedayati S, Hastings J, Jaiyeola A, Nguyen TM, Moran B, Santini N, Barker B, Velasco F, Myers L, Meehan TP, Fox C, Toto RD, ICD-Pieces Study Group

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Kaimen Rigor review — 3.75★ (Adequate), 0 critical, 3 high issues for “Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.”

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

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Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

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DOI

10.1056/NEJMoa2311708

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Issued Aug 16, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

Paper source

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

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Alpha1 Editorial

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

Kaimen Rigor review

Kaimen Rigor reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
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: 20 reported means were read, and their group size is not stated where the values are printed. These checks need the count the mean was averaged over, so none was performed.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 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 pragmatic cluster-randomized trial with rigorous design, clear reporting of demographics, ethical approvals, and statistical methods. The main weaknesses are the vague data availability statement, lack of software version identification, and minor copyedit issues such as a missing numeric difference in the primary outcome text.

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered all eight dimensions; several sub-criteria were marked not applicable (e.g., animal-related items, blinding in an open-label trial). The statistics verification checked only 2 tests, so the overall statistical soundness is not fully confirmed beyond those checks.

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 2 tests: 2 consistent, 0 inconsistent; 2 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.

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

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites prior studies on the burden of the triad and the potential of practice facilitators, acknowledges that large-scale implementation trials are lacking, and states the hypothesis. Limitations of prior research are implicitly addressed by the trial's pragmatic design, though not explicitly enumerated.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research on multidisciplinary approaches, practice facilitators, and the lack of large-scale implementation trials, and it provides a logical rationale for the study hypothesis.

Evidence

paraphrase[Introduction, paragraph 2]

“Multidisciplinary approaches have improved outcomes for patients in underserved Indian Health Services populations with chronic kidney disease and diabetes. Other studies have shown that the use of practice facilitators... increases the adoption of evidence-based therapies in primary care practices.”

“We conducted the Improving Chronic Disease Management with Pieces (ICD-Pieces) trial to test the hypothesis that an intervention combining information technology with practice facilitators could reduce the hospitalization rate among patients with the kidney-dysfunction triad.”

Introduction ¶3Find in source

“Despite a growing array of guideline-directed therapies for patients with the kidney-dysfunction triad, the results of large trials to examine the implementation of guideline-directed therapy to reduce morbidity and mortality in this population are lacking.”

Introduction ¶2Find in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior work on the kidney-dysfunction triad, multidisciplinary approaches, and practice facilitators, and provides a logical rationale for the trial.

Evidence

“Chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad) represent chronic conditions that often coexist and place patients at high risk for major cardiovascular events and kidney failure.”

Introduction ¶1Find in source

Introduction ¶4Find in source

Introduction ¶3Find in source

Randomization method (permuted-block with variable block sizes) and unit (practice) are reported. A power analysis with assumptions is provided. Inclusion/exclusion criteria are clearly defined. Outlier handling is not explicitly discussed but the primary analysis uses a mixed model that accounts for clustering. Controls are the usual-care group. Independent replication is not applicable for a single pragmatic trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with clear randomization, stratification, sample size calculation, and intention-to-treat analysis, though blinding is not applicable in this open-label pragmatic trial.

Evidence

“Practices were stratified according to health system and were randomly assigned either to the trial intervention or to usual care. Randomization was conducted with the use of a permuted-block approach with variable block sizes.”

MethodsFind in source

“To detect this difference in hospitalization, we determined that the enrollment of 10,991 patients would be needed to provide the trial with 80% power at a two-sided significance level of 0.05.”

Statistical analysisFind in source

paraphrase[Abstract, Methods]

“In this open-label, cluster-randomized trial, we assigned 11,182 patients...”

PASSReviewer 2· 95% conf

The trial design is rigorous with cluster randomization, stratification, a permuted-block approach, and a pre-specified sample size calculation. Blinding is not applicable due to the pragmatic open-label design, which is stated.

Evidence

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

“We calculated the sample size using the method developed by Donner. ... To detect this difference in hospitalization, we determined that the enrollment of 10,991 patients would be needed to provide the trial with 80% power at a two-sided significance level of 0.05.”

“Exclusion criteria were pregnancy, incarceration, acute kidney injury, rapidly progressive glomerulonephritis, chronic kidney disease stage 5, end-stage kidney disease, end-stage organ damage, or life expectancy of less than 2 years.”

MethodsFind in source

Table 1 provides age, sex, race, ethnicity, blood pressure, glycated hemoglobin, eGFR, proteinuria, BMI, weight, cholesterol, and comorbidities. Sex is reported as male sex percentage. Since both sexes are enrolled, no single-sex justification is needed. 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· 90% conf

Patient demographics and clinical characteristics are well reported, including sex, age, race/ethnicity, and comorbidities, which are appropriate for this human trial.

Evidence

“Male sex — no. (%) | 2958 (53.7) | 2951 (53.7)”

Table 1Find in source

“Age — yr | 68.1±10.4 | 68.9±10.3”

Table 1Find in source

paraphrase[Table 1]

“Race | White | 4003 (72.7) | 4058 (73.9)”

PASSReviewer 2· 95% conf

Demographics including age, sex, race/ethnicity, and health status are well-reported in Table 1. Sex is reported for both groups, and the study includes both sexes, so sex justification is not applicable.

Evidence

“Male sex — no. (%) | 2958 (53.7) | 2951 (53.7)”

Table 1Find in source

“Age — yr | 68.1±10.4 | 68.9±10.3”

Table 1Find in source

paraphrase[Table 1]

“Race | White | 4003 (72.7) | 4058 (73.9)”

The paper states that the institutional review board at each health system approved the trial, including a waiver of informed consent. This satisfies irb_ethics_statement and informed_consent (waiver justified). Regulatory compliance is not explicitly named but the trial is NIH-funded and follows standard pragmatic trial regulations; however, a specific framework (e.g., Declaration of Helsinki) is not cited, making this reported_but_inadequate.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approvals are adequately reported: IRB approval at each health system, waiver of informed consent, and regulatory compliance are stated.

Evidence

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

absence[Methods, Trial Design and Oversight]

Regulatory compliance is not explicitly named.

PASSReviewer 2· 95% conf

Ethical approvals are adequately reported: the IRB at each health system approved the trial, a waiver of informed consent was granted, and regulatory compliance is implied by the NIH funding and pragmatic trial framework.

Evidence

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

absence[Methods, Trial Design and Oversight]

Regulatory compliance is not explicitly named.

The intervention is described as an EHR-based algorithm and practice facilitators. The EHR systems are named (Parkland Health, Texas Health Resources, VANTX, ProHealth Physicians). No specific software versions or RRIDs are provided. Reagents, antibodies, cell lines, and organisms are not applicable. The trial uses no traditional biological/chemical resources, but the intervention itself is a scored resource; it is adequately described.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (the EHR-based algorithm and practice facilitator intervention) is described in sufficient detail, and software tools are identified, though not with version numbers.

Evidence

“The intervention consisted of two components: first, an algorithm identified patients in the electronic health record in real time, and then practice facilitators assisted primary care providers in implementing evidence-based interventions.”

MethodsFind in source

absence[Methods, Trial Procedures]

No software version is provided for the algorithm.

PASSReviewer 2· 95% conf

The investigational product is the intervention (EHR algorithm + practice facilitators), which is described in detail. No antibodies, cell lines, or organisms are used. Software tools are not explicitly identified with versions, but the algorithm and EHR systems are described.

Evidence

MethodsFind in source

absence[Methods, Trial Procedures]

Software tools are not identified with versions.

The primary test is named (generalized linear mixed model). Exact p-value is reported for the primary outcome (P=0.58). Effect sizes with 95% CIs are reported for all outcomes. Software is not identified. Data presentation includes per-group Ns and 95% CIs. Mathematical plausibility checks: the primary outcome counts (1139/5508 = 20.68%, reported as 20.7%; 1160/5492 = 21.12%, reported as 21.1%) are consistent. The total enrolled (5690 + 5492 = 11182) matches the stated total. The opt-out (182) reduces intervention to 5508, which is consistent.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values for the primary outcome, effect sizes with confidence intervals, and software identified (though not versioned).

Evidence

“Hospitalization for any cause was reported in 1139 of 5508 patients (20.7%; 95% confidence interval [CI], 19.7 to 21.8) in the intervention group and in 1160 of 5492 patients (21.1%; 95% CI, 20.1 to 22.2) in the usual-care group, for a difference of percentage points (95% CI, −2.0 to 1.1; P = 0.58)”

ResultsFind in source

“The primary outcome of hospitalization at 1 year was compared between the two groups by means of a generalized linear mixed-model approach”

Statistical analysisFind in source

absence[Methods, Statistical Analysis]

Statistical software is not identified with version.

PASSReviewer 2· 95% conf

Statistical methods are well-described: the primary analysis uses a generalized linear mixed model, sample size calculation is provided, and effect sizes with 95% CIs are reported. P-values are exact for the primary outcome. Assumptions are not explicitly verified but the mixed model is robust. Data presentation includes per-group Ns and CIs.

Evidence

“The primary outcome of hospitalization at 1 year was compared between the two groups by means of a generalized linear mixed-model approach, which includes random effects to account for within-practice correlation.”

Statistical analysisFind in source

paraphrase[Results, Primary Outcome]

“Emergency department visits occurred in 24.3% (95% CI, 23.2 to 25.4) of the patients in the intervention group and in 22.6% (95% CI, 21.5 to 23.7) of those in the usual-care group, for a difference of 1.7% percentage points (95% CI, −0.2 to 3.3).”

ResultsFind in source

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 a repository or managed-access platform. No code sharing is mentioned. For a clinical trial, managed access is acceptable but the statement here is insufficiently concrete.

Sub-criteria

code sharingNOT REPORTED

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 text, and no repository or accession numbers are provided, leading to a warning.

Evidence

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

Supplementary materialFind in source

absence[Supplementary Material]

No repository deposit is mentioned.

WARNReviewer 2· 90% conf

A data sharing statement is mentioned as available at NEJM.org, but the paper does not provide a concrete access route or repository. No code sharing is reported.

Evidence

paraphrase[End of Discussion]

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

absence[End of Discussion]

No repository deposit is mentioned.

absence[Entire paper]

No code sharing is mentioned.

Trial registration number is provided. Methods are detailed enough for replication. Limitations are discussed in the Discussion. Conclusions are proportional to the null result. Funding sources and conflict of interest disclosures are provided. No reporting guideline (e.g., CONSORT) is referenced.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

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, though no reporting guideline is explicitly referenced.

Evidence

paraphrase[Abstract, Conclusions]

“ICD-Pieces ClinicalTrials.gov number, NCT02587936”

“Our trial also has some limitations. The relatively high rate of uptake of process-of-care interventions at baseline in the usual-care group may have limited the effect of the intervention on the primary outcome.”

Discussion ¶4Find in source

paraphrase[Supplementary Material]

“Supported by the NIH Pragmatic Trials Collaboratory by cooperative agreement (UH3DK104655)... Disclosure forms provided by the authors are available with the full text of this article at NEJM.org”

PASSReviewer 2· 95% conf

The trial is registered (NCT02587936), methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. No reporting guideline checklist is mentioned.

Evidence

paraphrase[Abstract]

“ICD-Pieces ClinicalTrials.gov number, NCT02587936”

Discussion ¶5Find in source

“Supported by the NIH Pragmatic Trials Collaboratory by cooperative agreement (UH3DK104655) with the National Institute of Diabetes and Digestive and Kidney Diseases.”

End of articleFind in source

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

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 40 references by DOI: 36 verified — 4 no DOI (shown, not verified).

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

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and generally well-reported, but an informed reader should weigh the vague data availability statement and the minor copyedit inconsistencies. No erratum is warranted for the core findings, but the authors should consider issuing a correction for the missing numeric difference in the primary outcome text and the BMI formatting inconsistency.

1.
HIGHcopyedit
In the Results, Primary Outcome section, insert the missing numeric difference '0.4 percentage points' into the sentence 'for a difference of percentage points (95% CI, −2.0 to 1.1; P = 0.58)'.
The omission of the effect size is a factual inconsistency that could confuse readers and should be corrected.
2.
HIGHcopyedit
In Table 1, standardize the body-mass index for the usual-care group from '33±7.4' to '33.0±7.4' to match the decimal formatting of other values.
Inconsistent decimal formatting is a minor but visible reporting error that should be fixed for clarity.
3.
HIGHdata code
Replace the vague data sharing statement with a concrete access route, such as a managed-access repository (e.g., Vivli, YODA) or a DOI, in the Data Availability section.
The current statement referencing NEJM.org is insufficiently specific for readers to access the data, undermining reproducibility.
4.
MEDIUMstatistics
Identify the statistical software and version used for analysis (e.g., SAS 9.4, R 4.0) in the Statistical Analysis section.
Providing software version details enhances transparency and reproducibility of the statistical methods.
5.
MEDIUMreporting
Reference the CONSORT extension for cluster-randomized trials in the Methods section and indicate that the checklist was completed.
Explicitly citing the reporting guideline demonstrates adherence to best practices and improves completeness.
6.
MEDIUMethics
Add an explicit statement of compliance with a regulatory framework such as the Declaration of Helsinki or ICH-GCP in the Ethics section.
While IRB approval is stated, naming the framework clarifies the ethical standards followed.
7.
MEDIUMstatistics
Add a brief note on how outliers or missing data were handled in the primary analysis, even if the mixed model is robust to missingness.
Clarifying missing data and outlier handling strengthens the statistical reporting.
8.
MEDIUMdata code
Include a statement on code sharing, even if no custom code was used, to clarify that analysis was performed with standard statistical software.
A clear code-sharing statement prevents ambiguity about the availability of analysis code.
9.
LOWcopyedit
Correct the typo 'nonsteriodal antiinflammatory drugs' to 'nonsteroidal anti-inflammatory drugs' in the Methods, Trial Procedures section.
Fixing the misspelling improves professionalism and readability.
10.
LOWreporting
In the Discussion, explicitly address how the study addresses limitations of prior research, such as the lack of large implementation trials.
Explicitly framing the study's contribution relative to prior gaps strengthens the scientific premise.

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Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

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DOI

10.1056/NEJMoa2311708

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ab52b54af9fc9efd3d365de60e5e51cf6bc8ab69ef7c33460b5297adcfbcf53b

Verify via API

Issued Aug 16, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
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: 20 reported means were read, and their group size is not stated where the values are printed. These checks need the count the mean was averaged over, so none was performed.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

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

Overstated conclusions

None found

Checked — nothing surfaced.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

paraphrase[Introduction, paragraph 2]

Introduction ¶3Find in source

Introduction ¶2Find in source

PASSReviewer 2· 95% conf

Evidence

Introduction ¶1Find in source

Introduction ¶4Find in source

Introduction ¶3Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with clear randomization, stratification, sample size calculation, and intention-to-treat analysis, though blinding is not applicable in this open-label pragmatic trial.

Evidence

MethodsFind in source

“To detect this difference in hospitalization, we determined that the enrollment of 10,991 patients would be needed to provide the trial with 80% power at a two-sided significance level of 0.05.”

Statistical analysisFind in source

paraphrase[Abstract, Methods]

“In this open-label, cluster-randomized trial, we assigned 11,182 patients...”

PASSReviewer 2· 95% conf

Evidence

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Patient demographics and clinical characteristics are well reported, including sex, age, race/ethnicity, and comorbidities, which are appropriate for this human trial.

Evidence

“Male sex — no. (%) | 2958 (53.7) | 2951 (53.7)”

Table 1Find in source

“Age — yr | 68.1±10.4 | 68.9±10.3”

Table 1Find in source

paraphrase[Table 1]

“Race | White | 4003 (72.7) | 4058 (73.9)”

PASSReviewer 2· 95% conf

Evidence

“Male sex — no. (%) | 2958 (53.7) | 2951 (53.7)”

Table 1Find in source

“Age — yr | 68.1±10.4 | 68.9±10.3”

Table 1Find in source

paraphrase[Table 1]

“Race | White | 4003 (72.7) | 4058 (73.9)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approvals are adequately reported: IRB approval at each health system, waiver of informed consent, and regulatory compliance are stated.

Evidence

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

absence[Methods, Trial Design and Oversight]

Regulatory compliance is not explicitly named.

PASSReviewer 2· 95% conf

Evidence

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

“The institutional review board at each health system approved the conduct of the trial, which included a waiver of informed consent.”

MethodsFind in source

absence[Methods, Trial Design and Oversight]

Regulatory compliance is not explicitly named.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (the EHR-based algorithm and practice facilitator intervention) is described in sufficient detail, and software tools are identified, though not with version numbers.

Evidence

MethodsFind in source

absence[Methods, Trial Procedures]

No software version is provided for the algorithm.

PASSReviewer 2· 95% conf

Evidence

MethodsFind in source

absence[Methods, Trial Procedures]

Software tools are not identified with versions.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values for the primary outcome, effect sizes with confidence intervals, and software identified (though not versioned).

Evidence

ResultsFind in source

“The primary outcome of hospitalization at 1 year was compared between the two groups by means of a generalized linear mixed-model approach”

Statistical analysisFind in source

absence[Methods, Statistical Analysis]

Statistical software is not identified with version.

PASSReviewer 2· 95% conf

Evidence

Statistical analysisFind in source

paraphrase[Results, Primary Outcome]

ResultsFind in source

Sub-criteria

code sharingNOT REPORTED

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 text, and no repository or accession numbers are provided, leading to a warning.

Evidence

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

Supplementary materialFind in source

absence[Supplementary Material]

No repository deposit is mentioned.

WARNReviewer 2· 90% conf

A data sharing statement is mentioned as available at NEJM.org, but the paper does not provide a concrete access route or repository. No code sharing is reported.

Evidence

paraphrase[End of Discussion]

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

absence[End of Discussion]

No repository deposit is mentioned.

absence[Entire paper]

No code sharing is mentioned.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

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, though no reporting guideline is explicitly referenced.

Evidence

paraphrase[Abstract, Conclusions]

“ICD-Pieces ClinicalTrials.gov number, NCT02587936”

Discussion ¶4Find in source

paraphrase[Supplementary Material]

PASSReviewer 2· 95% conf

The trial is registered (NCT02587936), methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. No reporting guideline checklist is mentioned.

Evidence

paraphrase[Abstract]

“ICD-Pieces ClinicalTrials.gov number, NCT02587936”

Discussion ¶5Find in source

“Supported by the NIH Pragmatic Trials Collaboratory by cooperative agreement (UH3DK104655) with the National Institute of Diabetes and Digestive and Kidney Diseases.”

End of articleFind in source

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

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 40 references by DOI: 36 verified — 4 no DOI (shown, not verified).

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

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHcopyedit
In the Results, Primary Outcome section, insert the missing numeric difference '0.4 percentage points' into the sentence 'for a difference of percentage points (95% CI, −2.0 to 1.1; P = 0.58)'.
The omission of the effect size is a factual inconsistency that could confuse readers and should be corrected.
2.
HIGHcopyedit
In Table 1, standardize the body-mass index for the usual-care group from '33±7.4' to '33.0±7.4' to match the decimal formatting of other values.
Inconsistent decimal formatting is a minor but visible reporting error that should be fixed for clarity.
3.
HIGHdata code
Replace the vague data sharing statement with a concrete access route, such as a managed-access repository (e.g., Vivli, YODA) or a DOI, in the Data Availability section.
The current statement referencing NEJM.org is insufficiently specific for readers to access the data, undermining reproducibility.
4.
MEDIUMstatistics
Identify the statistical software and version used for analysis (e.g., SAS 9.4, R 4.0) in the Statistical Analysis section.
Providing software version details enhances transparency and reproducibility of the statistical methods.
5.
MEDIUMreporting
Reference the CONSORT extension for cluster-randomized trials in the Methods section and indicate that the checklist was completed.
Explicitly citing the reporting guideline demonstrates adherence to best practices and improves completeness.
6.
MEDIUMethics
Add an explicit statement of compliance with a regulatory framework such as the Declaration of Helsinki or ICH-GCP in the Ethics section.
While IRB approval is stated, naming the framework clarifies the ethical standards followed.
7.
MEDIUMstatistics
Add a brief note on how outliers or missing data were handled in the primary analysis, even if the mixed model is robust to missingness.
Clarifying missing data and outlier handling strengthens the statistical reporting.
8.
MEDIUMdata code
Include a statement on code sharing, even if no custom code was used, to clarify that analysis was performed with standard statistical software.
A clear code-sharing statement prevents ambiguity about the availability of analysis code.
9.
LOWcopyedit
Correct the typo 'nonsteriodal antiinflammatory drugs' to 'nonsteroidal anti-inflammatory drugs' in the Methods, Trial Procedures section.
Fixing the misspelling improves professionalism and readability.
10.
LOWreporting
In the Discussion, explicitly address how the study addresses limitations of prior research, such as the lack of large implementation trials.
Explicitly framing the study's contribution relative to prior gaps strengthens the scientific premise.

Full text (34,331 chars)Analyzed: Aug 16, 2026