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Kaimen Rigor review

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

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

DOI: 10.1056/NEJMoa2311708
Record issued: 2026-08-16
Engine: 7.39.0
Exported: 2026-09-22

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/7a2ce24f-34eb-4be3-b351-d1a52aa6f219 is authoritative.

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.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p = .580 · recomputed p = .568Reviewer 1
Primary outcome hospitalization rate comparison using reported counts and totals.
“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)”
Find in source
Taken as given: The counts 1139 and 1160 are the number of hospitalizations in each group.; The totals 5508 and 5492 are the group sizes.; The p-value is from a two-sided test comparing two proportions.
Method: Pearson chi-square test for 2x2 table using cell counts.
How we recomputed it: pChi2x2(1139, 5508-1139, 1160, 5492-1160)
CONSISTENTreported p = .580 · recomputed p = .568Reviewer 2
Primary outcome: hospitalization at 1 year, intervention vs usual care, using a generalized linear mixed model. The reported p-value is 0.58. We can approximate using a chi-square test on the 2x2 table of events/total.
“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).”
Find in source
Taken as given: The 1139 and 1160 are the event counts in the intervention and usual-care groups respectively.; The 5508 and 5492 are the total patients in each group.; A chi-square test approximates the mixed model result (the paper used a mixed model, but the p-value is similar).
Method: Pearson chi-square test on 2x2 table of events vs non-events.
How we recomputed it: pChi2x2(1139, 5508-1139, 1160, 5492-1160)

lowinternal contradiction
The text in the Results section for the primary outcome omits the numeric difference (0.4 percentage points) that appears in the abstract, which could be a typographical omission.
“for a difference of percentage points (95% CI, −2.0 to 1.1; P = 0.58)”
ResultsFind in source
lowinternal contradiction
The baseline table shows body-mass index for usual care as '33±7.4' without a decimal, while all other values have one decimal, suggesting a formatting inconsistency.
“Body-mass index | 33.4±7.6 | 33±7.4”
Table 1Find in source

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.

supportedReviewer 1
The intervention did not reduce hospitalization at 1 year.
The primary outcome analysis shows no significant difference between groups, supporting the claim.
Evidence: Primary outcome: 20.7% vs 21.1%, difference 0.4 percentage points, P=0.58.
“the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year.”
ConclusionFind in source
supportedReviewer 1
Secondary outcomes were similar between groups.
All secondary outcomes show overlapping confidence intervals and no significant differences, supporting the claim.
Evidence: Secondary outcomes table shows similar rates with CIs overlapping zero.
Secondary outcomes were similar in the two groups.
Resultsreviewer’s wording
supportedReviewer 1
Acute kidney injury was more common in the intervention group.
The adverse events table shows a higher rate in the intervention group (12.7% vs 11.3%), supporting the claim.
Evidence: Table 4: Acute kidney injury 701 (12.7) vs 619 (11.3).
“Acute kidney injury was the most common adverse event and was reported in 701 of 5508 patients (12.7%) in the intervention group and in 619 of 5492 patients (11.3%) in the usual-care group.”
ResultsFind in source
supportedReviewer 1
The trial enrolled a representative population with high inclusion of underrepresented groups.
The baseline characteristics show a diverse population with about 20% Black and 20% Hispanic patients, supporting the claim.
Evidence: Table 1 shows race and ethnicity distributions.
“Our trial design enabled the participation of a high fraction of underrepresented groups, thus making our findings generalizable.”
Discussion ¶3Find in source
supportedReviewer 1
The intervention improved process-of-care measures.
The implementation table shows higher rates of updated problem lists, patient education, and new ACE inhibitor/ARB prescriptions in the intervention group, supporting the claim.
Evidence: Table 3 shows higher percentages in intervention for several process measures.
“More patients in the intervention group had an updated problem list, had adopted targets for blood pressure and glycated hemoglobin, and had documentation of the receipt of education regarding the kidney-dysfunction triad.”
ResultsFind in source
supportedReviewer 2
The intervention did not reduce hospitalization at 1 year compared to usual care.
The primary outcome analysis directly supports this claim with a non-significant p-value and overlapping confidence intervals.
Evidence: Primary outcome: 20.7% vs 21.1%, difference -0.4 percentage points (95% CI -2.0 to 1.1, P=0.58).
“The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P = 0.58).”
AbstractFind in source
supportedReviewer 2
Secondary outcomes (ED visits, readmissions, cardiovascular events, dialysis, death) were similar between groups.
All secondary outcomes show overlapping confidence intervals and small absolute differences, supporting similarity.
Evidence: Table 2 and Results section report point estimates and 95% CIs for each secondary outcome, all with overlapping intervals.
Secondary outcomes were similar in the two groups.
Resultsreviewer’s wording
supportedReviewer 2
The intervention improved process-of-care measures (e.g., problem list updates, goal setting, patient education).
Table 3 shows higher percentages in the intervention group for several process measures, based on a 10% random sample chart review.
Evidence: Table 3: e.g., 'Met all criteria: problem list updated and patient education received' 64% vs 39%.
“More patients in the intervention group had an updated problem list, had adopted targets for blood pressure and glycated hemoglobin, and had documentation of the receipt of education regarding the kidney-dysfunction triad.”
ResultsFind in source
supportedReviewer 2
Adverse events were similar between groups except for acute kidney injury, which was higher in the intervention group.
Table 4 shows similar rates for most adverse events, with acute kidney injury at 12.7% vs 11.3%.
Evidence: Table 4: Acute kidney injury 701/5508 (12.7%) vs 619/5492 (11.3%).
“Acute kidney injury was the most common adverse event and was reported in 701 of 5508 patients (12.7%) in the intervention group and in 619 of 5492 patients (11.3%) in the usual-care group.”
ResultsFind in source

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.

ClinicalTrials.gov

NCT02587936

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).

NO DOI
2022 USRDS annual data report: epidemiology of kidney disease in the United States
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Fequently asked questions — 2 midnight inpatient admission guidance and patient status reviews for admissions on or after October 1, 2013
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Sample size determination for clustered outcomes
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Digital health’s role in managing chronic disease
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

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

datahttps://NEJM.orgUNVERIFIEDHTTP 403
Liveness indeterminate — content not checked.
datahttps://clinicaltrials.gov/ct2/show/NCT02587936LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

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.

MINORtypoMethods, Trial Procedures
“nonsteriodal antiinflammatory drugs”
→ nonsteroidal anti-inflammatory drugs
Misspelling of 'nonsteroidal'.
MINORconsistencyResults, Primary Outcome
“for a difference of percentage points”
→ for a difference of 0.4 percentage points
The difference value is missing in the text.
MINORconsistencyTable 1
“Body-mass index | 33.4±7.6 | 33±7.4”
→ 33.0±7.4
Inconsistent decimal formatting for the usual-care group.
MINORconsistencyResults, Primary Outcome
“for a difference of percentage points (95% CI, −2.0 to 1.1; P = 0.58)”
→ for a difference of -0.4 percentage points (95% CI, −2.0 to 1.1; P = 0.58)
The difference value (-0.4) is missing from the sentence.

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.

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

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

DOI

10.1056/NEJMoa2311708

Record issued

2026-08-16

Engine

7.39.0

Exported

2026-09-22