Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Name: Kaimen Rigor review — Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.
Item: Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.
Rating: 96
Author: Alpha1

Gohil SK, Septimus E, Kleinman K, Varma N, Avery TR, Heim L, Rahm R, Cooper WS, Cooper M, McLean LE, Nickolay NG, Weinstein RA, Burgess LH, Coady MH, Rosen E, Sljivo S, Sands KE, Moody J, Vigeant J, Rashid S, Gilbert RF, Smith KN, Carver B, Poland RE, Hickok J, Sturdevant SG, Calderwood MS, Weiland A, Kubiak DW, Reddy S, Neuhauser MM, Srinivasan A, Jernigan JA, Hayden MK, Gowda A, Eibensteiner K, Wolf R, Perlin JB, Platt R, Huang SS

Paper source

Read full text (PMC)PDF

Embed this Rigor badge

Kaimen Rigor review — 2.25★ (Weak), 0 critical, 2 high issues for “Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.”

Links back to this Kaimen Rigor review.

Alpha1 Editorial

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

Read alongside

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Read full text (PMC)

Open PDF

DOI

10.1001/jama.2024.6248

Share this Kaimen Rigor review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://alpha1science.com/verify/fc42ca9e-a7c9-4270-a58e-9dc4989bdbe9" target="_blank" rel="noopener">
  <img src="https://alpha1science.com/verify/fc42ca9e-a7c9-4270-a58e-9dc4989bdbe9/badge" alt="Kaimen Rigor review — 2.25★ (Weak), 0 critical, 2 high issues for “Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.”" width="440" height="104" style="max-width:100%;height:auto" />
</a>

Every embed links back to this Kaimen Rigor review.

Record fingerprint

fb9a59a03bdf2c16a73db0301976d8a5d84a36914f03fa740ed600e2a3555318

Verify via API

Issued Aug 16, 2026Engine 7.39.0

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

Alpha¹ by Kaimen

Fetching the latest research

Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Paper source

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Read full text (PMC)PDF

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

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

Kaimen Rigor review

Kaimen Rigor reviewed

2.25 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−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: 1 reported mean was read, and its group size is not stated where the value is 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.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcome is extended-spectrum antibiotic days of therapy, a process measure (antibiotic use) rather than a hard clinical outcome. The paper does not provide evidence linking reduced antibiotic use to improved clinical outcomes; safety outcomes (ICU transfer, length of stay) were unchanged, and no validated surrogate-to-clinical outcome link is established.
“The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy.”
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The reported 28.4% reduction in extended-spectrum antibiotic days of therapy is a relative reduction in a process measure, not anchored to a clinically meaningful threshold or patient benefit. The absolute reduction from 613.9 to 428.5 days per 1000 empiric days is not framed against a minimal clinically important difference, and safety outcomes were unchanged, so the clinical meaningfulness is unclear.
“a 28.4% (95% CI, 22.2%-34.1%; P <.001) significantly lower rate of empiric extended-spectrum days of therapy in the CPOE bundle group compared with routine stewardship.”
03Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT03697070 was first submitted to ClinicalTrials.gov on 2018-10-03, after the registered study start date of 2018-10-01. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT03697070
reviewer’s wording

Findings by category

101ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 103AuthenticityData authenticity concerns 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit5 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 cluster-randomized trial with a clear premise, rigorous design, comprehensive demographic reporting, and appropriate statistical methods. The main weaknesses are a vague data availability statement and a minor lack of explicit blinding rationale. Several minor copyedit inconsistencies in reported numbers should be corrected.

Both reviewers independently scored all eight dimensions and agreed on every status; no divergence required reconciliation. The study is interventional (cluster-randomized trial). Non-applicable sub-criteria (e.g., species/strain, housing, IACUC) were excluded. The statistics verification covered only 6 tests/effect estimates; the rest are unverified. The citation check found no retracted or unresolved references.

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 6 tests: 6 consistent, 0 inconsistent; 6 via agent-written checks.

Overstated conclusions

3 findings · worst high

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.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

8 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

1 finding · worst medium

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.

Other integrity concernAssessed

3 integrity concerns flagged (0 high).

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 studies on antibiotic overuse and stewardship strategies, acknowledges limitations of prior approaches (e.g., focusing on duration rather than initial selection), and provides a logical rationale linking the premise to the objective of reducing empiric extended-spectrum antibiotic use. Limitations of prior research are addressed by the novel real-time risk-based prompt approach.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work and a logical rationale for the intervention.

Evidence

paraphrase[Introduction, paragraph 1]

“Estimates suggest that about half of patients admitted with pneumonia unnecessarily receive extended-spectrum antibiotics. ... strategies to improve prescribing for inpatient pneumonia have largely focused on shortening antibiotic duration or de-escalating extended-spectrum antibiotics after microbiologic tests return and patients are stabilized.”

“Real-time identification of patients with low risk for MDRO pneumonia might therefore reduce empiric extended-spectrum antibiotic exposure.”

Introduction ¶2

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work and a logical rationale for the intervention.

Evidence

paraphrase[Introduction, paragraph 1]

“Real-time identification of patients with low risk for MDRO pneumonia might therefore reduce empiric extended-spectrum antibiotic exposure.”

Introduction ¶2

Randomization was performed within matched pairs using Mahalanobis distance, with a 1:1 ratio. The unit of randomization was the hospital (cluster). Blinding is not explicitly described, but the nature of the intervention (CPOE prompts) makes blinding of clinicians infeasible; the paper does not state this rationale explicitly. Power analysis is reported (97% power to detect 12.5% difference). Inclusion/exclusion criteria are clearly defined. Outlier handling is addressed through sensitivity analyses and pre-specified analysis populations. Controls are inherent in the routine stewardship group. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsINADEQUATE

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 cluster-randomized design is rigorous with adequate randomization, blinding considerations, power analysis, and pre-specified outcomes.

Evidence

paraphrase[Methods, Randomization]

“Hospitals were randomized in a 1:1 ratio ... Randomization was performed within these pairs.”

paraphrase[Methods, Trial Outcomes]

“The study had 97% (95% CI, 91%-99%) power to detect a 12.5% difference in extended-spectrum days of therapy between the intervention and routine stewardship groups during the first 3 days.”

absence[Methods]

Blinding is not explicitly described.

PASSReviewer 2· 95% conf

The cluster-randomized design is rigorous with adequate randomization, blinding considerations, power analysis, and pre-specified outcomes.

Evidence

paraphrase[Methods, Randomization]

“Hospitals were randomized in a 1:1 ratio ... Randomization was performed within these pairs.”

paraphrase[Methods, Trial Outcomes]

“The study had 97% (95% CI, 91%-99%) power to detect a 12.5% difference in extended-spectrum days of therapy between the intervention and routine stewardship groups during the first 3 days.”

absence[Methods, Study Design and Intervention]

Blinding is not explicitly described.

Sex, age, race/ethnicity, comorbidities, and health status are reported in Table 1. Since both sexes are enrolled, sex justification 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· 90% conf

Patient demographics and clinical characteristics are comprehensively reported.

Evidence

“Sex a Male 12,852 (48.4) 11,869 (47.6) 10,966 (48.2) 10,545 (48.1) Female 13,710 (51.5) 13,085 (52.3) 11,768 (51.7) 11,400 (51.8)”

Table 1

PASSReviewer 2· 90% conf

Patient demographics and clinical characteristics are comprehensively reported, including sex, age, race/ethnicity, and comorbidities.

Evidence

“the mean (SD) age of patients was 68.1 (17.0) years, 48.1% were men”

Results

paraphrase[Table 1]

“Race Black 3,194 (12.0) ... Hispanic/Latino Ethnicity 5,308 (19.9)”

The paper states that the Harvard Pilgrim Health Care Institute IRB provided centralized oversight, and individual informed consent was waived. This satisfies both IRB approval and consent handling. Regulatory compliance is implied through IRB oversight and CONSORT reporting.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and consent waiver are clearly documented.

Evidence

“The Harvard Pilgrim Health Care Institute Institutional Review Board provided centralized oversight, with reliance agreements and operational committee approvals from participating hospitals. Individual informed consent was waived.”

Methods

PASSReviewer 2· 95% conf

Ethical approval and consent waiver are clearly documented.

Evidence

“The Harvard Pilgrim Health Care Institute Institutional Review Board provided centralized oversight, with reliance agreements and operational committee approvals from participating hospitals.”

Methods

“Individual informed consent was waived.”

Methods

The intervention is a CPOE prompt system, not a drug or device. The paper describes the algorithm and the EHR system (MEDITECH). Statistical software (SAS 9.4, R 4.0.0) is identified. No antibodies, cell lines, or organisms are used, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

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 product (CPOE prompts) and software are adequately identified.

Evidence

“All analyses were performed using SAS version 9.4 (SAS Institute) or R version 4.0.0 (R Foundation).”

Statistical analysis

PASSReviewer 2· 90% conf

The investigational product (CPOE prompts) and software are adequately identified; no bench reagents are used.

Evidence

“Hospitals were eligible to participate if they used the MEDITECH electronic health record (EHR) system”

Methods

“All analyses were performed using SAS version 9.4 (SAS Institute) or R version 4.0.0 (R Foundation).”

Statistical analysis

Tests are named (generalized linear mixed-effects models, proportional hazards models). Assumptions are handled by design (clustering accounted for). Exact p-values are reported (e.g., P < .001). Effect sizes with 95% CIs are provided. Software is identified. Data presentation includes per-group n and rates. Mathematical plausibility checks were not possible for all numbers due to complex models, but no obvious errors were found.

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 effect sizes with confidence intervals.

Evidence

“The overall rate ratio (RR) when clustering by hospital and period was 0.72 (95% CI, 0.66- 0.78; P < .001) for the primary outcome”

Results

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Methods, Statistical Analysis]

“Unadjusted as-randomized outcomes were assessed using generalized linear mixed-effects models ... Each safety outcome was assessed using as-randomized unadjusted proportional hazards models”

paraphrase[Results, Primary and Secondary Trial Outcomes]

“The overall rate ratio (RR) when clustering by hospital and period was 0.72 (95% CI, 0.66-0.78; P < .001)”

The paper states 'Data Sharing Statement: See Supplement 3.' This is vague and does not specify a concrete access route. No repository deposit or accession numbers are provided. No custom code is shared.

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

Data availability statement is present but vague, and no code is shared.

Evidence

“Data Sharing Statement: See Supplement 3.”

End of paper

WARNReviewer 2· 80% conf

Data availability statement is present but vague; no repository deposit or code sharing.

Evidence

“Data Sharing Statement: See Supplement 3.”

End of paper

Trial registration number is provided (NCT03697070). CONSORT guidelines are mentioned. All outcomes are reported, including safety outcomes. Limitations are explicitly discussed. Conclusions are proportional to the evidence. Funding and COI disclosures are provided.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, reported per CONSORT, and limitations are discussed.

Evidence

paraphrase[Methods, Hospital Recruitment and Study Cohort Definition]

“This trial was registered with ClinicalTrials.gov (NCT03697070). Results are reported according to CONSORT guidelines.”

“There are several limitations in this study. First, the trial was performed in private community hospitals and applicability to other settings is unknown.”

Limitations

PASSReviewer 2· 95% conf

The trial is registered, reported per CONSORT, and includes limitations and funding/COI disclosures.

Evidence

“Trial Registration ClinicalTrials.gov Identifier: NCT03697070”

Abstract

paraphrase[Methods, Hospital Recruitment and Study Cohort Definition]

“Results are reported according to CONSORT guidelines.”

“There are several limitations in this study. First, the trial was performed in private community hospitals and applicability to other settings is unknown.”

Limitations

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

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: 28 verified — 3 no DOI (shown, not verified).

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and trustworthy, with no major rigor gaps. An informed reader should weigh the vague data availability statement and the retrospective registration as minor transparency limitations. The copyedit inconsistencies in reported numbers are minor and do not affect conclusions, but a correction or erratum could clarify them.

1.
HIGHdata code
Replace the vague 'Data Sharing Statement: See Supplement 3.' with a concrete description of data access conditions, including the managed-access platform or data-access committee, contact, and timeframe.
The current statement is inadequate for a data-driven clinical trial and fails to meet reproducibility expectations.
2.
HIGHreporting
Add a statement in the Methods (Study Design and Intervention) explaining that blinding of clinicians was not feasible due to the nature of the CPOE intervention, and describe any blinding of outcome assessors or data analysts.
The absence of any blinding description is a reporting gap that reviewers flagged.
3.
MEDIUMdata code
Deposit de-identified aggregate data or a data dictionary in a public repository (e.g., Dryad, Zenodo) with a DOI, if permissible under privacy constraints.
A concrete repository deposit would strengthen reproducibility and transparency.
4.
MEDIUMdata code
Share custom analysis code (e.g., for the MDRO risk models) in a public repository (e.g., GitHub) with a version and DOI.
Code sharing is not mentioned and would enhance the reproducibility of the analyses.
5.
MEDIUMcopyedit
Reconcile the abstract's '48.1% were men' with Table 1's baseline male percentage (48.4%) and ensure consistent rounding or denominator.
The internal contradiction between the abstract and Table 1 could confuse readers.
6.
MEDIUMcopyedit
Fix the spacing in '23 078/26 ,640' to '23,078/26,640' in the Results section.
Spacing inconsistency in numbers is a typographical error that should be corrected.
7.
MEDIUMcopyedit
Verify the denominator for the routine stewardship baseline group: 25,031 in text vs 25,030 in one percentage calculation, and correct the inconsistency.
A denominator discrepancy could be a typo but should be resolved to avoid confusion.
8.
LOWreporting
Add a note in the Methods about how missing data (e.g., unknown sex) were handled in the analysis.
Clarifying missing data handling improves methodological transparency.
9.
LOWreporting
Consider describing the CPOE prompt software version and any custom code used for the algorithm to improve software identification.
More specific software identification would strengthen the key_resources reporting.
10.
LOWreporting
Add a statement on whether any independent replication or validation cohort is planned or available.
Addressing replication potential would strengthen the study's generalizability discussion.

Full text (53,228 chars)Analyzed: Aug 16, 2026

Start the discussion on JRNLClub

Community discussion on jrnlclub.com

Read alongside

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Read full text (PMC)

Open PDF

DOI

10.1001/jama.2024.6248

Share this Kaimen Rigor review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://alpha1science.com/verify/fc42ca9e-a7c9-4270-a58e-9dc4989bdbe9" target="_blank" rel="noopener">
  <img src="https://alpha1science.com/verify/fc42ca9e-a7c9-4270-a58e-9dc4989bdbe9/badge" alt="Kaimen Rigor review — 2.25★ (Weak), 0 critical, 2 high issues for “Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.”" width="440" height="104" style="max-width:100%;height:auto" />
</a>

Every embed links back to this Kaimen Rigor review.

Record fingerprint

fb9a59a03bdf2c16a73db0301976d8a5d84a36914f03fa740ed600e2a3555318

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

2.25 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−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: 1 reported mean was read, and its group size is not stated where the value is 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.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcome is extended-spectrum antibiotic days of therapy, a process measure (antibiotic use) rather than a hard clinical outcome. The paper does not provide evidence linking reduced antibiotic use to improved clinical outcomes; safety outcomes (ICU transfer, length of stay) were unchanged, and no validated surrogate-to-clinical outcome link is established.
“The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy.”
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The reported 28.4% reduction in extended-spectrum antibiotic days of therapy is a relative reduction in a process measure, not anchored to a clinically meaningful threshold or patient benefit. The absolute reduction from 613.9 to 428.5 days per 1000 empiric days is not framed against a minimal clinically important difference, and safety outcomes were unchanged, so the clinical meaningfulness is unclear.
“a 28.4% (95% CI, 22.2%-34.1%; P <.001) significantly lower rate of empiric extended-spectrum days of therapy in the CPOE bundle group compared with routine stewardship.”
03Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT03697070 was first submitted to ClinicalTrials.gov on 2018-10-03, after the registered study start date of 2018-10-01. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT03697070
reviewer’s wording

Findings by category

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 6 tests: 6 consistent, 0 inconsistent; 6 via agent-written checks.

Overstated conclusions

3 findings · worst high

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

8 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

1 finding · worst medium

Other integrity concernAssessed

3 integrity concerns flagged (0 high).

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· 90% conf

The paper establishes a clear scientific premise with prior work and a logical rationale for the intervention.

Evidence

paraphrase[Introduction, paragraph 1]

“Real-time identification of patients with low risk for MDRO pneumonia might therefore reduce empiric extended-spectrum antibiotic exposure.”

Introduction ¶2

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work and a logical rationale for the intervention.

Evidence

paraphrase[Introduction, paragraph 1]

“Real-time identification of patients with low risk for MDRO pneumonia might therefore reduce empiric extended-spectrum antibiotic exposure.”

Introduction ¶2

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsINADEQUATE

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 cluster-randomized design is rigorous with adequate randomization, blinding considerations, power analysis, and pre-specified outcomes.

Evidence

paraphrase[Methods, Randomization]

“Hospitals were randomized in a 1:1 ratio ... Randomization was performed within these pairs.”

paraphrase[Methods, Trial Outcomes]

“The study had 97% (95% CI, 91%-99%) power to detect a 12.5% difference in extended-spectrum days of therapy between the intervention and routine stewardship groups during the first 3 days.”

absence[Methods]

Blinding is not explicitly described.

PASSReviewer 2· 95% conf

The cluster-randomized design is rigorous with adequate randomization, blinding considerations, power analysis, and pre-specified outcomes.

Evidence

paraphrase[Methods, Randomization]

“Hospitals were randomized in a 1:1 ratio ... Randomization was performed within these pairs.”

paraphrase[Methods, Trial Outcomes]

“The study had 97% (95% CI, 91%-99%) power to detect a 12.5% difference in extended-spectrum days of therapy between the intervention and routine stewardship groups during the first 3 days.”

absence[Methods, Study Design and Intervention]

Blinding is not explicitly described.

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 comprehensively reported.

Evidence

“Sex a Male 12,852 (48.4) 11,869 (47.6) 10,966 (48.2) 10,545 (48.1) Female 13,710 (51.5) 13,085 (52.3) 11,768 (51.7) 11,400 (51.8)”

Table 1

PASSReviewer 2· 90% conf

Patient demographics and clinical characteristics are comprehensively reported, including sex, age, race/ethnicity, and comorbidities.

Evidence

“the mean (SD) age of patients was 68.1 (17.0) years, 48.1% were men”

Results

paraphrase[Table 1]

“Race Black 3,194 (12.0) ... Hispanic/Latino Ethnicity 5,308 (19.9)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and consent waiver are clearly documented.

Evidence

Methods

PASSReviewer 2· 95% conf

Ethical approval and consent waiver are clearly documented.

Evidence

“The Harvard Pilgrim Health Care Institute Institutional Review Board provided centralized oversight, with reliance agreements and operational committee approvals from participating hospitals.”

Methods

“Individual informed consent was waived.”

Methods

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

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 product (CPOE prompts) and software are adequately identified.

Evidence

“All analyses were performed using SAS version 9.4 (SAS Institute) or R version 4.0.0 (R Foundation).”

Statistical analysis

PASSReviewer 2· 90% conf

The investigational product (CPOE prompts) and software are adequately identified; no bench reagents are used.

Evidence

“Hospitals were eligible to participate if they used the MEDITECH electronic health record (EHR) system”

Methods

“All analyses were performed using SAS version 9.4 (SAS Institute) or R version 4.0.0 (R Foundation).”

Statistical analysis

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 effect sizes with confidence intervals.

Evidence

“The overall rate ratio (RR) when clustering by hospital and period was 0.72 (95% CI, 0.66- 0.78; P < .001) for the primary outcome”

Results

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Methods, Statistical Analysis]

“Unadjusted as-randomized outcomes were assessed using generalized linear mixed-effects models ... Each safety outcome was assessed using as-randomized unadjusted proportional hazards models”

paraphrase[Results, Primary and Secondary Trial Outcomes]

“The overall rate ratio (RR) when clustering by hospital and period was 0.72 (95% CI, 0.66-0.78; P < .001)”

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

Data availability statement is present but vague, and no code is shared.

Evidence

“Data Sharing Statement: See Supplement 3.”

End of paper

WARNReviewer 2· 80% conf

Data availability statement is present but vague; no repository deposit or code sharing.

Evidence

“Data Sharing Statement: See Supplement 3.”

End of paper

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, reported per CONSORT, and limitations are discussed.

Evidence

paraphrase[Methods, Hospital Recruitment and Study Cohort Definition]

“This trial was registered with ClinicalTrials.gov (NCT03697070). Results are reported according to CONSORT guidelines.”

“There are several limitations in this study. First, the trial was performed in private community hospitals and applicability to other settings is unknown.”

Limitations

PASSReviewer 2· 95% conf

The trial is registered, reported per CONSORT, and includes limitations and funding/COI disclosures.

Evidence

“Trial Registration ClinicalTrials.gov Identifier: NCT03697070”

Abstract

paraphrase[Methods, Hospital Recruitment and Study Cohort Definition]

“Results are reported according to CONSORT guidelines.”

“There are several limitations in this study. First, the trial was performed in private community hospitals and applicability to other settings is unknown.”

Limitations

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

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: 28 verified — 3 no DOI (shown, not verified).

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Replace the vague 'Data Sharing Statement: See Supplement 3.' with a concrete description of data access conditions, including the managed-access platform or data-access committee, contact, and timeframe.
The current statement is inadequate for a data-driven clinical trial and fails to meet reproducibility expectations.
2.
HIGHreporting
Add a statement in the Methods (Study Design and Intervention) explaining that blinding of clinicians was not feasible due to the nature of the CPOE intervention, and describe any blinding of outcome assessors or data analysts.
The absence of any blinding description is a reporting gap that reviewers flagged.
3.
MEDIUMdata code
Deposit de-identified aggregate data or a data dictionary in a public repository (e.g., Dryad, Zenodo) with a DOI, if permissible under privacy constraints.
A concrete repository deposit would strengthen reproducibility and transparency.
4.
MEDIUMdata code
Share custom analysis code (e.g., for the MDRO risk models) in a public repository (e.g., GitHub) with a version and DOI.
Code sharing is not mentioned and would enhance the reproducibility of the analyses.
5.
MEDIUMcopyedit
Reconcile the abstract's '48.1% were men' with Table 1's baseline male percentage (48.4%) and ensure consistent rounding or denominator.
The internal contradiction between the abstract and Table 1 could confuse readers.
6.
MEDIUMcopyedit
Fix the spacing in '23 078/26 ,640' to '23,078/26,640' in the Results section.
Spacing inconsistency in numbers is a typographical error that should be corrected.
7.
MEDIUMcopyedit
Verify the denominator for the routine stewardship baseline group: 25,031 in text vs 25,030 in one percentage calculation, and correct the inconsistency.
A denominator discrepancy could be a typo but should be resolved to avoid confusion.
8.
LOWreporting
Add a note in the Methods about how missing data (e.g., unknown sex) were handled in the analysis.
Clarifying missing data handling improves methodological transparency.
9.
LOWreporting
Consider describing the CPOE prompt software version and any custom code used for the algorithm to improve software identification.
More specific software identification would strengthen the key_resources reporting.
10.
LOWreporting
Add a statement on whether any independent replication or validation cohort is planned or available.
Addressing replication potential would strengthen the study's generalizability discussion.

Full text (53,228 chars)Analyzed: Aug 16, 2026