Effect of a clinical decision support system on stroke care quality and outcomes in patients with acute ischaemic stroke (GOLDEN BRIDGE II): cluster randomised clinical trial.
Zhang X, Ding L, Jing J, Wang C, Gu H, Jiang Y, Meng X, Liu T, Xie X, Xu M, Hu M, Zhang Y, Fu H, Liu P, Du C, Du K, Wang M, Li H, Gong X, Dong K, Xiong Y, Wang Y, Liu L, Zhang Z, Zang Y, Yang C, Xian Y, Peterson E, Fonarow GC, Schwamm LH, Zhao X, Wang Y, Li Z, GOLDEN BRIDGE II Investigators
- DOI
- 10.1136/bmj-2025-085810
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-20
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/eebb7a44-9e65-4772-994e-c9f041094697 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
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 transparently reported cluster randomised trial of a CDSS for acute ischaemic stroke. The design is rigorous with appropriate randomisation, blinding, sample size calculation, and statistical methods. Minor reporting gaps (e.g., code repository, missing data handling, observed ICC) and copyedit issues do not undermine the core findings.
Both reviewers classified the study as interventional; no divergence. The evaluation covered the full text, including methods, results, and supplementary materials. Non-applicable criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only a subset of reported tests (13 of many); the absence of detected errors does not confirm the correctness of all analyses.
Numerical inconsistencies
1 finding · worst lowValues 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 13 tests: 13 consistent, 0 inconsistent; 11 recomputed directly from the reported test statistics, 2 via agent-written checks.
- CONSISTENTreported p = .010 · recomputed p = .012Recomputed adjusted hazard ratio 0.74 (95% CI 0.58–0.93), reported p=0.01
“adjusted hazard ratio 0.74, 95% confidence interval (CI) 0.58 to 0.93, P=0.01”
Taken as given: 0.58–0.93 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.74, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.01 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.74, 0.58, 0.93, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed adjusted odds ratio 1.21 (95% CI 1.17–1.26), reported p<0.001
“adjusted odds ratio 1.21, 95% CI 1.17 to 1.26, P<0.001”
Taken as given: 1.17–1.26 is a two-sided 95% confidence interval for the adjusted odds ratio of 1.21, not a range, an IQR, or a different interval level; the adjusted odds ratio is a RATIO measure, so the interval is symmetric on the log scale; p<0.001 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(1.21, 1.17, 1.26, 1) - CONSISTENTreported p = .020 · recomputed p = .020Recomputed adjusted hazard ratio 0.73 (95% CI 0.56–0.95), reported p=0.02
“adjusted hazard ratio 0.73, 95% CI 0.56 to 0.95, P=0.02”
Taken as given: 0.56–0.95 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.73, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.02 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.73, 0.56, 0.95, 1) - CONSISTENTreported p = .006 · recomputed p = .006Recomputed adjusted hazard ratio 0.70 (95% CI 0.54–0.90), reported p=0.006
“adjusted hazard ratio 0.70, 95% CI 0.54 to 0.90, P=0.006”
Taken as given: 0.54–0.90 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.70, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.006 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.7, 0.54, 0.9, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed odds ratio 1.21 (95% CI 1.17–1.26), reported p<0.001
“odds ratio 1.21, 95% CI 1.17 to 1.26, P<0.001”
Taken as given: 1.17–1.26 is a two-sided 95% confidence interval for the odds ratio of 1.21, not a range, an IQR, or a different interval level; the odds ratio is a RATIO measure, so the interval is symmetric on the log scale; p<0.001 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(1.21, 1.17, 1.26, 1) - CONSISTENTreported p = .290 · recomputed p = .292Recomputed adjusted odds ratio 1.18 (95% CI 0.87–1.61), reported p=0.29
“adjusted odds ratio 1.18, 95% CI 0.87 to 1.61, P=0.29”
Taken as given: 0.87–1.61 is a two-sided 95% confidence interval for the adjusted odds ratio of 1.18, not a range, an IQR, or a different interval level; the adjusted odds ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.29 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(1.18, 0.87, 1.61, 1) - CONSISTENTreported p = .006 · recomputed p = .006Recomputed adjusted hazard ratio 0.71 (95% CI 0.56–0.91), reported p=0.006
“adjusted hazard ratio 0.71, 95% CI 0.56 to 0.91, P=0.006”
Taken as given: 0.56–0.91 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.71, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.006 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.71, 0.56, 0.91, 1) - CONSISTENTreported p = .290 · recomputed p = .274Recomputed adjusted odds ratio 1.14 (95% CI 0.90–1.44), reported p=0.29
“adjusted odds ratio 1.14, 95% CI 0.90 to 1.44, P=0.29”
Taken as given: 0.90–1.44 is a two-sided 95% confidence interval for the adjusted odds ratio of 1.14, not a range, an IQR, or a different interval level; the adjusted odds ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.29 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(1.14, 0.9, 1.44, 1) - CONSISTENTreported p = .680 · recomputed p = .663Recomputed adjusted hazard ratio 0.91 (95% CI 0.60–1.40), reported p=0.68
“adjusted hazard ratio 0.91, 95% CI 0.60 to 1.40, P=0.68”
Taken as given: 0.60–1.40 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.91, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.68 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.91, 0.6, 1.4, 1) - CONSISTENTreported p = .740 · recomputed p = .745Recomputed adjusted hazard ratio 0.89 (95% CI 0.44–1.79), reported p=0.74
“adjusted hazard ratio 0.89, 95% CI 0.44 to 1.79, P=0.74”
Taken as given: 0.44–1.79 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.89, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.74 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.89, 0.44, 1.79, 1) - CONSISTENTreported p = .130 · recomputed p = .132Recomputed adjusted hazard ratio 0.68 (95% CI 0.41–1.12), reported p=0.13
“adjusted hazard ratio 0.68, 95% CI 0.41 to 1.12, P=0.13”
Taken as given: 0.41–1.12 is a two-sided 95% confidence interval for the adjusted hazard ratio of 0.68, not a range, an IQR, or a different interval level; the adjusted hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.13 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.68, 0.41, 1.12, 1) - CONSISTENTreported p = .010 · recomputed p = .012Reviewers 1, 2Primary outcome hazard ratio p-value from CI
“adjusted hazard ratio 0.74 (95% confidence interval (CI) 0.58 to 0.93, P=0.01)”
Taken as given: The hazard ratio is 0.74 with 95% CI 0.58 to 0.93.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.74, 0.58, 0.93, 1) - CONSISTENTreported p = .020 · recomputed p = .020Reviewers 1, 212-month new vascular events hazard ratio p-value from CI
“adjusted hazard ratio 0.73, 95% CI 0.56 to 0.95, P=0.02”
Taken as given: The hazard ratio is 0.73 with 95% CI 0.56 to 0.95.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.73, 0.56, 0.95, 1)
- lowinternal contradictionThe abstract reports 21 603 patients enrolled, but the methods state 21 689 were enrolled and 86 withdrew, which is consistent. However, the abstract says '77 hospitals (38 randomised to intervention group, 39 to control group) enrolled 21 603 patients' while the methods say '77 hospitals from 23 provinces were included and randomly assigned' after excluding three that declined. This is consistent.
“77 hospitals (38 randomised to intervention group, 39 to control group) enrolled 21 603 patients with acute ischaemic stroke admitted to hospital within seven days after symptom onset.”
AbstractFind in source - lowinternal contradictionThe paper reports that the primary outcome occurred in 2.9% (320/11 054) in the intervention group and 3.9% (416/10 549) in the control group. The absolute difference is 1.0%, but the cluster-level analysis reports an effect size of -0.01, which is consistent.
“New vascular events at three months occurred in 2.9% (320/11 054) in the intervention group compared with 3.9% (416/10 549) in the control group (adjusted hazard ratio 0.74, 95% confidence interval (CI) 0.58 to 0.93, P=0.01).”
ResultsFind in source
Overstated conclusions
None foundConclusions 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.
5 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewers 1, 2Use of the stroke CDSS led to a significant decrease in new vascular events at three months.The primary outcome analysis shows a statistically significant reduction in new vascular events at three months, with an adjusted hazard ratio of 0.74 (95% CI 0.58 to 0.93, P=0.01).Evidence: Primary outcome result: 2.9% vs 3.9%, adjusted HR 0.74 (95% CI 0.58 to 0.93, P=0.01).
“New vascular events at three months occurred in 2.9% (320/11 054) in the intervention group compared with 3.9% (416/10 549) in the control group (adjusted hazard ratio 0.74, 95% confidence interval (CI) 0.58 to 0.93, P=0.01).”
AbstractFind in source - supportedReviewers 1, 2The stroke CDSS intervention was also effective in improving stroke care quality.The composite measure of evidence-based performance measures was significantly higher in the intervention group (91.4% vs 89.8%, adjusted OR 1.21, 95% CI 1.17 to 1.26, P<0.001).Evidence: Composite measure result: 91.4% vs 89.8%, adjusted OR 1.21 (95% CI 1.17 to 1.26, P<0.001).
“Patients in the intervention group were more likely to have a higher composite measure (91.4% (77 049/84 276) v 89.8% (70 794/78 834), adjusted odds ratio 1.21, 95% CI 1.17 to 1.26, P<0.001).”
AbstractFind in source - supportedReviewers 1, 2The stroke CDSS intervention decreased long term vascular events.New vascular events were significantly lower at 6 and 12 months, with adjusted HRs of 0.71 and 0.73 respectively, both statistically significant.Evidence: Secondary outcome results: 6-month HR 0.71 (95% CI 0.56 to 0.91, P=0.006); 12-month HR 0.73 (95% CI 0.56 to 0.95, P=0.02).
“New vascular events were significantly lower in the intervention group at 12 months (4.0% (440/11 054) v 5.5% (576/10 549), adjusted hazard ratio 0.73, 95% CI 0.56 to 0.95, P=0.02).”
AbstractFind in source - supportedReviewers 1, 2No significant differences were found in disability and all cause mortality.All reported disability and mortality outcomes show non-significant p-values, supporting the claim.Evidence: Disability and mortality outcomes at 3, 6, and 12 months all have p-values >0.05.
“No significant differences were found in disability and all cause mortality.”
AbstractFind in source - supportedReviewers 1, 2Moderate or severe bleeding, and all bleeding did not differ significantly between the two groups.All bleeding outcomes show non-significant p-values, supporting the claim.Evidence: Safety outcomes at 3, 6, and 12 months all have p-values >0.05.
“Moderate or severe bleeding, and all bleeding did not differ significantly between the two groups.”
AbstractFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary endpoint is a hard clinical outcome: a composite of new vascular events (ischaemic stroke, haemorrhagic stroke, myocardial infarction, vascular death) at three months. No surrogate or biomarker is used as the primary basis for the efficacy claim.
“The primary outcome was a new vascular event (composite of ischaemic stroke, haemorrhagic stroke, myocardial infarction, and vascular death) within three months after initial symptom onset.”
- ADEQUATEEffect sizeThe primary effect is a 25.6% relative reduction in new vascular events (2.9% vs 3.9%, adjusted HR 0.74, 95% CI 0.58–0.93, P=0.01). The authors anchor this as clinically meaningful, noting the 1% absolute reduction is significant given the high burden of stroke, and the relative reduction aligns with the pre-specified hypothesis of 26%.
“the relative reduction in our study reached 25.6%, which was closely aligned with our initial research hypothesis of 26%... the 1% decrease could carry significance in clinical practice.”
Data authenticity concerns
None foundAn 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
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction cites GOLDEN BRIDGE-AIS and GWTG-Stroke as evidence that quality improvement interventions improve stroke care, and notes that AI applications for stroke have not been rigorously evaluated in RCTs. The rationale for the CDSS is clearly linked to the need for a comprehensive, evidence-based decision support tool. Limitations of prior work are implicitly addressed by the trial's design, though not explicitly discussed in the introduction.
“According to GOLDEN BRIDGE-AIS (Intervention to Bridge the Evidence-based Gap in Stroke Care Quality) and GWTG-Stroke (Get With The Guidelines-Stroke), implementing multifaceted quality improvement interventions improves acute ischaemic stroke care quality and outcomes.”
“CDSS may provide a new way to facilitate clinical decision making and consequently improve care quality and clinical outcomes in patients with ischaemic cerebrovascular disease.”
“However, the majority of AI applications for stroke healthcare have not been rigorously evaluated through randomised controlled trials.”
“According to GOLDEN BRIDGE-AIS (Intervention to Bridge the Evidence-based Gap in Stroke Care Quality) and GWTG-Stroke (Get With The Guidelines-Stroke), implementing multifaceted quality improvement interventions improves acute ischaemic stroke care quality and outcomes.”
“CDSS may provide a new way to facilitate clinical decision making and consequently improve care quality and clinical outcomes in patients with ischaemic cerebrovascular disease.”
“However, the majority of AI applications for stroke healthcare have not been rigorously evaluated through randomised controlled trials.”
Randomisation used a random number generator with stratification by hospital region and grade. Blinding was applied to follow-up interviewers and statisticians, though the trial was open-label for participants and physicians. A sample size calculation was provided with assumptions. Inclusion/exclusion criteria for hospitals and patients were specified. Outlier handling is not explicitly described, but the analysis population (ITT) and sensitivity analysis for contraindications are defined. Controls are the usual care group. Independent replication is not applicable for a single pivotal trial.
“Hospitals were randomly assigned in a 1:1 ratio to the CDSS intervention group or the usual care group through a random number generator. Randomisation was stratified by the hospital location (eastern, central, or western region) and hospital grade (secondary or tertiary).”
“To ensure blinding to cluster assignments, follow-up data were collected by interviewers who were masked to patients’ cluster assignments. Statisticians were masked to the cluster allocation.”
“We estimated that 21 689 participants from 80 hospitals would provide 80% power to detect a 26% relative reduction in the primary outcome, with a two sided significance level of 5%, an intraclass correlation coefficient of 0.01, and a 10% loss to follow-up.”
“Hospitals were randomly assigned in a 1:1 ratio to the CDSS intervention group or the usual care group through a random number generator.”
“To ensure blinding to cluster assignments, follow-up data were collected by interviewers who were masked to patients’ cluster assignments.”
“Therefore, we estimated that 21 689 participants from 80 hospitals would provide 80% power to detect a 26% relative reduction in the primary outcome, with a two sided significance level of 5%, an intraclass correlation coefficient of 0.01, and a 10% loss to follow-up.”
The paper reports age, sex, body mass index, and medical history (stroke, diabetes, hypertension, etc.) in Table 1. Since both sexes are enrolled, sex justification is not applicable. Age and health status are reported. Species/strain and housing conditions are not applicable for a human trial. Demographics are adequately reported.
“Age (years), median (IQR) | 67 (58-74) | 66 (57-74) | 3.2 | | Men | 7129 (64.5) | 6796 (64.4) | 0.1”
“Medical history | | Stroke | 2701 (24.4) | 2413 (22.9) | 3.7 | | Diabetes | 2359 (21.3) | 2379 (22.6) | 2.9”
“The median age of patients was 67 (57-74) years and 7678 (35.5%) were female.”
“Age (years), median (IQR) | 67 (58-74) | 66 (57-74) | 3.2”
The paper states approval by the central institutional review board at Beijing Tiantan Hospital (KY 2020-016-02) and each participating site. Written informed consent was obtained from all participants. Regulatory compliance is indicated by adherence to CONSORT-AI guidelines. This is a human trial, so IACUC is not applicable.
“The central institutional review board at Beijing Tiantan Hospital (KY 2020-016-02) and each participating site approved the trial protocol.”
“All patients or their legal guardians provided written informed consent before enrolment.”
“The study complied with the CONSORT-AI (consolidated standards of reporting trials—artificial intelligence) extension guidelines.”
“The central institutional review board at Beijing Tiantan Hospital (KY 2020-016-02) and each participating site approved the trial protocol.”
“All patients or their legal guardians provided written informed consent before enrolment.”
“The study complied with the CONSORT-AI (consolidated standards of reporting trials—artificial intelligence) extension guidelines.”
The stroke CDSS is the investigational product and is described in detail in the Methods and supplementary appendix. The statistical software (SAS 9.4) is identified. Antibodies, cell lines, mycoplasma, and organisms are not applicable as this is a clinical trial without wet-lab assays. Reagents are not applicable beyond the CDSS itself.
“All the analyses were performed using SAS software, version 9.4 (SAS Institute).”
“All the analyses were performed using SAS software, version 9.4 (SAS Institute).”
The paper names the statistical tests used (mixed effects Cox regression, weighted generalised linear regression, t-tests, Wilcoxon rank sum, chi-square, Fisher's exact). Assumptions are handled by design (mixed models, non-parametric tests). Exact p-values are reported for primary and secondary outcomes. Effect sizes with 95% CIs are reported. Software is identified. Data presentation includes Kaplan-Meier curves and per-group n. Mathematical plausibility checks were performed on reported percentages and counts; no inconsistencies were found.
“T tests or Wilcoxon rank sum tests were used for continuous variables, while χ 2 tests or Fisher’s exact tests were performed for categorical variables. We conducted a cluster level analysis using weighted generalised linear regression for the primary outcome.”
“New vascular events at three months occurred in 2.9% of patients in the stroke CDSS intervention group compared with 3.9% in the control group, with adjusted hazard ratio 0.74 (95% confidence interval (CI) 0.58 to 0.93, P=0.01).”
“The primary outcome of new vascular events at three months was assessed using a mixed effects Cox regression with a random effect of hospital.”
“New vascular events at three months occurred in 2.9% (320/11 054) in the intervention group compared with 3.9% (416/10 549) in the control group (adjusted hazard ratio 0.74, 95% confidence interval (CI) 0.58 to 0.93, P=0.01).”
The data availability statement names a public repository (NCMI) with a persistent identifier (CSTR). The code is stated to be in the supplementary appendix. Repository deposit and accession numbers are applicable and adequate. Code sharing is reported but the repository is not version-controlled with a DOI, but it is in the supplementary appendix, which is acceptable.
“The data underlying the study findings are openly and publicly available ( https://www.ncmi.cn/phda/dataDetails.do?id=CSTR:17970.11.A004X.202603.36.V2.0 ).”
“The code used to analyse the data in the paper can be found in the supplementary appendix.”
“The data underlying the study findings are openly and publicly available ( https://www.ncmi.cn/phda/dataDetails.do?id=CSTR:17970.11.A004X.202603.36.V2.0 ).”
“The code used to analyse the data in the paper can be found in the supplementary appendix.”
Trial registration number is provided (NCT04524624). CONSORT-AI is referenced. All pre-specified outcomes are reported, including null results. Limitations are explicitly discussed. Conclusions are proportional to the evidence. Funding sources and competing interests are disclosed.
“Trial registration ClinicalTrials.gov NCT04524624 (https://clinicaltrials.gov/ct2/show/NCT04524624)”
“This study has several limitations. The trial randomised hospitals rather than individual patients. Differences in care patterns and outcomes among the hospitals and subsequent outpatient care might affect these findings.”
“Trial registration ClinicalTrials.gov NCT04524624 (https://clinicaltrials.gov/ct2/show/NCT04524624)”
“The study complied with the CONSORT-AI (consolidated standards of reporting trials—artificial intelligence) extension guidelines.”
“This study has several limitations. The trial randomised hospitals rather than individual patients. Differences in care patterns and outcomes among the hospitals and subsequent outpatient care might affect these findings.”
Registered (3 IDs: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences 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 48 references by DOI: 45 verified — 3 no DOI (shown, not verified).
- NO DOIActs for Hospital ClassificationNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIBrief introduction: 2013 China statistical yearbookNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIMedical quality control indicators for cerebral infarction (2020 edition)No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link found; not probed for liveness in this run.
- datahttps://www.ncmi.cn/phda/dataDetails.do?id=CSTR:17970.11.A004X.202603.36.V2.0UNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
Copyediting
8 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 8 minor suggestions below.
8 copyedit issues flagged: mostly consistency, typo, clarity.
- MINORtypoAbstract, Results“acute ischaemic stoke”→ acute ischaemic strokeTypo in the abstract.
- MINORconsistencyMethods, Statistical analysis“A P value less than 0.05 or an absolute difference more than 10% were considered statistically significant”→ A P value less than 0.05 or an absolute difference more than 10% was considered statistically significantSubject-verb agreement.
- MINORclarityResults, Table 2“Effect size (95% Cl)”→ Effect size (95% CI)Inconsistent abbreviation for confidence interval.
- MINORconsistencyResults, Table 2“10 549(2.3)”→ 10 549 (2.3)Missing space before parenthesis.
- MINORtypoAbstract, Results“New vascular events at three months occurred in 2.9% (320/11 054) in the intervention group compared with 3.9% (416/10 549) in the control group”→ Consider rephrasing to 'New vascular events at three months occurred in 2.9% (320/11 054) of patients in the intervention group compared with 3.9% (416/10 549) in the control group'Minor clarity improvement.
- MINORconsistencyTable 2, footnote“Effect size (95% Cl)”→ Change 'Cl' to 'CI'Typographical error in the table header.
- MINORconsistencyResults, Secondary outcomes“The reduction in new vascular events persisted through longer term follow-up, with significantly lower rates in the intervention group at six months (3.4% v 4.8%, adjusted hazard ratio 0.71, 95% CI 0.56 to 0.91, P=0.006) and 12 months (4.0% v 5.5%, 0.73, 0.56 to 0.95, P=0.02).”→ Consider adding 'adjusted hazard ratio' before the second CI for clarity.Minor clarity improvement.
- MINORtypoDiscussion, Comparison with other studies“We observed that the rate of three month vascular events in our study (3.9% in the control group) was lower than the estimated rate of 6.4%, resulting in a smaller rate difference of 1% (compared with the estimated 1.7%).”→ Consider rephrasing for clarity.Minor clarity improvement.
The published work is robust and well-reported; an informed reader should weigh the minor reporting gaps (e.g., code not in a version-controlled repository, missing observed ICC, missing data handling details) as limitations but not as threats to validity. No erratum or correction appears warranted based on the checks performed.
- 1.MEDIUMdata codeAdd a version-controlled repository link (e.g., GitHub with DOI) for the analysis code in the Data availability statement, rather than only the supplementary appendix.A version-controlled repository with a DOI enhances reproducibility and is a common reviewer expectation for data-driven papers.
- 2.MEDIUMstatisticsReport the observed intraclass correlation coefficient (ICC) in the Results, as it was used in the sample size calculation but not reported.Reporting the observed ICC allows readers to assess the design assumptions against actual data.
- 3.MEDIUMstatisticsAdd a statement on how missing data for the primary outcome were handled (e.g., multiple imputation, complete-case analysis) in the Statistical analysis section.The paper only mentions loss to follow-up in the sample size calculation; explicit missing data handling improves transparency.
- 4.MEDIUMreportingClarify the blinding status of physicians and patients in the Randomisation and blinding section, noting the trial was open-label for participants and physicians.Avoids ambiguity about who was blinded and who was not, which is important for interpreting potential bias.
- 5.MEDIUMreportingAdd a statement on whether any data monitoring committee interim analyses were planned or conducted.Interim analysis plans are a standard element of trial reporting and affect interpretation of results.
- 6.MEDIUMreportingReport the number of patients excluded due to contraindications for each performance measure, and the number who withdrew within one day (86) with reasons.Improves transparency about the analysis population and potential selection bias.
- 7.MEDIUMreportingAdd a sensitivity analysis for the primary outcome using a per-protocol population, in addition to the ITT analysis.Per-protocol analysis can assess the robustness of the ITT findings to protocol deviations.
- 8.MEDIUMreportingAdd a note on the generalizability of findings to patients with severe stroke and to other countries, as the study population had mild strokes and was conducted only in China.Helps readers interpret the applicability of the results to broader populations.
- 9.LOWreportingReport the cost-effectiveness analysis results or state when they will be available, as mentioned in the limitations.Completes the picture of the intervention's value beyond clinical outcomes.
- 10.LOWcopyeditFix the typo 'acute ischaemic stoke' to 'acute ischaemic stroke' in the Abstract.Corrects a typographical error that could undermine professionalism.
- 11.LOWcopyeditCorrect subject-verb agreement in Methods, Statistical analysis: 'A P value less than 0.05 or an absolute difference more than 10% was considered statistically significant'.Fixes a grammatical error for clarity.
- 12.LOWcopyeditStandardize the abbreviation for confidence interval to 'CI' throughout, including Table 2 header where 'Cl' appears.Ensures consistency and avoids confusion.
- 13.LOWcopyeditAdd a space before parentheses in Table 2 entry '10 549(2.3)' to '10 549 (2.3)'.Improves readability and formatting consistency.
- 14.LOWcopyeditRephrase the abstract sentence to 'New vascular events at three months occurred in 2.9% (320/11 054) of patients in the intervention group compared with 3.9% (416/10 549) in the control group' for clarity.Clarifies that percentages refer to patients.
- 15.LOWcopyeditAdd 'adjusted hazard ratio' before the second CI in the secondary outcomes sentence for clarity.Avoids ambiguity about which statistic is reported.
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.”
- 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.
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.