Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.
Zhang L, Bi S, Chen L, Du L, He F, Qiao Y, Li Z, Zeng W, Zhao X, Chen X, Li X, Ding G, Zhou W, Sun B, Guo Q, Guo X, Jin F, Wang X, Zhu Q, Sun Q, Jiang S, Wang X, Cai F, Jiang Y, Gao J, Wang Z, Wang Z, Zhang L, Liu JM, Huang L, Yu L, Chen J, Zhang S, Poon LC, Li HT, Chen D, study’s collaborator group
- DOI
- 10.1136/bmj-2026-089636
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- 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/015b6f81-b7f7-498d-81b7-e54664d380ec is authoritative.
How this rating was calculated
- ReportingEthical approvals partially met−0.25★
- ReportingData & code availability partially met−0.25★
- CitationsUnresolved reference−0.25★
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.
A methodologically strong, well-conducted randomised double-blind placebo-controlled phase 3 trial with rigorous randomisation, blinding, sample size calculation, and transparent reporting including trial registration, outcome disclosure, and proportional conclusions. The main weaknesses are reporting gaps rather than design flaws: no explicit regulatory-compliance (Declaration of Helsinki) statement, data deposited on a GitHub user page without a persistent identifier/DOI, no CONSORT guideline statement, and one reference not found in any registry.
Both reviewers evaluated the full text and agreed on all eight statuses; minor divergence occurred on whether demographics and code-sharing are fully adequate (race/ethnicity and permanent-identifier omissions respectively), which did not change statuses. Statistics verification covered only 2 recomputable tests (partial coverage); N/A dimensions excluded species/housing (human trial) and antibodies/cell lines. Citation check flagged 1 reference not found in any registry; 0 retracted.
Numerical inconsistencies
None foundValues 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.
Checked — nothing surfaced.
Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.
- CONSISTENTreported p = .010 · recomputed p = .010Reviewer 1Verify the primary outcome p-value from the reported RR and 95.2% CI.
“relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01”
Taken as given: The RR is from a log-binomial mixed effects model with adjustment for center, age group, and placenta praevia type.; The CI is a 95.2% Wald-type CI, so the z-value for the CI is approximately 1.976 (from (1-0.048)/2).; The p-value is two-tailed from the same model.Method: pCI function from the sandbox, which computes p from estimate and CI on log scale for ratio.How we recomputed it: pCI(0.85, 0.75, 0.96, 1) - CONSISTENTreported p = .010 · recomputed p = .010Reviewer 2Recompute the two-sided p-value for the primary outcome relative risk from the reported CI, assuming a normal approximation.
“The primary outcome occurred in 29.7% (251/845) of the tranexamic acid group and 35.1% (297/846) of the placebo group (relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01).”
Taken as given: The relative risk is 0.85 and the 95.2% CI is 0.75 to 0.96, as quoted.; The pCI function assumes a normal approximation with a two-sided 95% CI; the paper used a 95.2% CI, so the recomputed p is approximate.; The RR is on a log scale (log=1).Method: Used pCI with log=1 to derive a two-sided p-value from the reported RR and CI; compared to the reported P=0.01.How we recomputed it: pCI(0.85, 0.75, 0.96, 1)
Overstated conclusions
1 finding · worst lowConclusions 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.
- Conclusions only partially backed by the presented evidenceAssessed
8 major claims checked against the paper's own evidence: all adequately supported.
- partialReviewer 1The reduction in postpartum haemorrhage is modest but clinically meaningful.The absolute risk reduction is 5.4% (35.1% to 29.7%), and the NNT is 19. The authors describe it as 'modest', which is consistent with the data, but the clinical meaningfulness is subjective and not directly tested.Evidence: Absolute risk reduction 5.4%, NNT 19 (95% CI 10 to 104).
The number needed to treat to prevent one event was 19 for postpartum haemorrhage… These values are lower than those reported in two previous trials involving low risk or mixed risk populations… suggesting that tranexamic acid may have greater clinical utility in patients at high risk of postpartum haemorrhage.
Discussionreviewer’s wording - partialReviewer 1Tranexamic acid may have greater clinical utility in high-risk patients than in low-risk populations.The lower NNT compared to prior trials is cited as support, but this is a cross-trial comparison and not a direct head-to-head comparison, so the claim is partially supported.Evidence: NNT of 19 vs higher NNTs in TRAAP2 and other trials.
“These values are lower than those reported in two previous trials involving low risk or mixed risk populations (∼50% unscheduled caesarean delivery), suggesting that tranexamic acid may have greater clinical utility in patients at high risk of postpartum haemorrhage.”
DiscussionFind in source - partialReviewer 2These values are lower than those reported in two previous trials involving low risk or mixed risk populations, suggesting that tranexamic acid may have greater clinical utility in patients at high risk of postpartum haemorrhage.The NNT comparison is indirect and based on cross-trial comparisons; the claim that greater clinical utility is suggested is an inference, not a direct finding.Evidence: Comparison of NNTs with TRAAP and TRAAP2 trials.
“These values are lower than those reported in two previous trials involving low risk or mixed risk populations (∼50% unscheduled caesarean delivery), suggesting that tranexamic acid may have greater clinical utility in patients at high risk of postpartum haemorrhage.”
DiscussionFind in source - supportedReviewer 1In women with placenta praevia undergoing caesarean delivery, prophylactic tranexamic acid reduces the incidence of postpartum haemorrhage.The primary outcome data show a statistically significant reduction (RR 0.85, 95.2% CI 0.75-0.96, P=0.01), supporting the claim.Evidence: Primary outcome: 29.7% vs 35.1%, RR 0.85, P=0.01.
“The primary outcome occurred in 29.7% (251/845) of the tranexamic acid group and 35.1% (297/846) of the placebo group (relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01).”
Table 2Find in source - supportedReviewer 1The rates of serious adverse events are similar between tranexamic acid and placebo.Safety data show comparable rates (0.5% vs 0.5%, RR 1.01, 95% CI 0.25-4.00), with wide CIs but no signal of increased risk.Evidence: Table 3: 0.5% (4/837) vs 0.5% (4/845), RR 1.01 (95% CI 0.25-4.00).
“Overall, 0.5% (4 of 837) of participants in the tranexamic acid group and 0.5% (4 of 845) in the placebo group experienced a serious adverse event (relative risk 1.01, 0.25 to 4.00).”
Table 3Find in source - supportedReviewer 2In women with placenta praevia who underwent caesarean delivery and received prophylactic oxytocin, treatment with tranexamic acid resulted in a statistically significant yet modest reduction in the incidence of postpartum haemorrhage.The primary outcome (RR 0.85, 95.2% CI 0.75-0.96, P=0.01) directly supports this claim.Evidence: Primary outcome analysis: 29.7% vs 35.1%, RR 0.85.
“In women with placenta praevia who underwent caesarean delivery and received prophylactic oxytocin, treatment with tranexamic acid resulted in a statistically significant yet modest reduction in the incidence of postpartum haemorrhage”
ConclusionFind in source - supportedReviewer 2No signal of increased serious adverse events was observed.Serious adverse event rates were identical (0.5% in both groups, RR 1.01, 95% CI 0.25-4.00), supporting the claim.Evidence: Safety analysis: 4/837 vs 4/845 serious adverse events.
“with no signal of increased serious adverse events”
AbstractFind in source - supportedReviewer 2The number needed to treat to prevent one event was 19 for postpartum haemorrhage.The NNT is directly reported from the trial data.Evidence: NNT calculated from primary outcome rates.
The number needed to treat was 19 (95% CI 10 to 104) for postpartum haemorrhage
Resultsreviewer’s wording
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary outcome is postpartum haemorrhage, defined by calculated estimated blood loss ≥1000 mL or red cell transfusion within two days. This is a hard clinical outcome, not a surrogate biomarker.
“The primary outcome was postpartum haemorrhage, defined as calculated estimated blood loss ≥1000 mL or as red cell transfusion within two days after delivery.”
- ADEQUATEEffect sizeThe effect is a relative risk of 0.85 (95% CI 0.75–0.96), absolute reduction from 35.1% to 29.7%, with NNT of 19. The authors explicitly describe it as 'statistically significant yet modest' and anchor it with NNT and clinical utility, so the effect is both statistically supported and anchored to clinical meaningfulness.
“tranexamic acid treatment resulted in a statistically significant yet modest reduction in the incidence of postpartum haemorrhage. The number needed to treat to prevent one event was 19 for postpartum haemorrhage.”
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
2 findings · worst mediumRequired 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
- Ethics/consent reporting incompleteAssessed
The introduction cites prior work (TRAAP, TRAAP2) and explicitly identifies the gap in high-risk populations. The rationale logically links the premise to the study objectives. Limitations of prior research (selective enrolment in low-risk populations) are addressed.
“Therefore, we conducted a randomised, double blind, placebo controlled trial to investigate whether tranexamic acid could reduce the incidence of postpartum haemorrhage without increasing the risk of adverse events in women with placenta praevia undergoing caesarean delivery.”
“Tranexamic acid, an antifibrinolytic agent that inhibits plasmin mediated fibrinolysis, has been shown to effectively reduce the incidence of postpartum haemorrhage during caesarean delivery in low risk populations. However, no evidence exists for tranexamic acid reducing more severe maternal outcomes, including maternal mortality or the need for blood transfusion during caesarean section.”
“Notably, previous studies have predominantly enrolled participants from low risk or mixed risk (∼50% unscheduled caesarean delivery) populations. Such selective enrolment has left a critical gap in prophylactic use of tranexamic acid in high risk patients”
“Therefore, we conducted a randomised, double blind, placebo controlled trial to investigate whether tranexamic acid could reduce the incidence of postpartum haemorrhage without increasing the risk of adverse events in women with placenta praevia undergoing caesarean delivery.”
Randomisation method (centralised, block size 6, stratified) and unit (individual patient) are reported. Double-blinding of participants, investigators, staff, sponsor, and data analysts is stated. A power analysis is provided with attrition allowance. Inclusion/exclusion criteria are detailed. For a human RCT, applicable sub-criteria (randomization_method, randomization_unit, blinding_levels, power_analysis, inclusion_exclusion, outlier_handling, controls) are all reported and adequate.
“Study investigators randomly assigned patients in a 1:1 ratio using a centralised computer generated randomisation (Sun Yat-sen University Cancer Centre, Guangzhou, China) with a block size of six to receive either tranexamic acid or placebo. Randomisation was stratified according to the study site, maternal age group (≥35 or <35 years), and placenta praevia type (low lying placenta or placenta praevia).”
“Participants, investigators, clinical staff, the study sponsor, and the data analysts were masked to treatment assignment.”
“To achieve 80% power in detecting a ≥20% relative difference in incidence (33% in the placebo group versus 26.4% in the tranexamic acid group) at a two sided type I error rate of 5%, the required sample size was determined to be 1500 (750 in each group) based on a standard two sample test for comparing proportions.”
“Study investigators randomly assigned patients in a 1:1 ratio using a centralised computer generated randomisation (Sun Yat-sen University Cancer Centre, Guangzhou, China) with a block size of six”
“Participants, investigators, clinical staff, the study sponsor, and the data analysts were masked to treatment assignment.”
“To achieve 80% power in detecting a ≥20% relative difference in incidence (33% in the placebo group versus 26.4% in the tranexamic acid group) at a two sided type I error rate of 5%, the required sample size was determined to be 1500 (750 in each group) based on a standard two sample test for comparing proportions.”
All participants are pregnant women (sex female, inherent to condition). Age, BMI, health status (comorbidities), and detailed demographics (education, parity, gestational age, etc.) are reported in Table 1. Sex justification is not applicable as the study is specific to pregnancy. Species, strain, and housing are not applicable.
“Women with confirmed placenta praevia during their last prenatal ultrasound examination”
“Mean (SD) age (years) | 33.8 (4.3) | 34.0 (4.4)”
The trial was approved by the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University (ethics review No 045) on 30 May 2023, and other centres obtained approval before enrolment. Written informed consent was obtained from all patients or legally authorised representatives. However, no statement of adherence to a recognised framework such as the Declaration of Helsinki or ICH-GCP is present.
“The trial was approved the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University on 30 May 2023 (ethics review No 045).”
“All patients or their legally authorised representatives (ie, spouse or parents) provided written informed consent before randomisation.”
“The trial was approved the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University on 30 May 2023 (ethics review No 045).”
“All patients or their legally authorised representatives (ie, spouse or parents) provided written informed consent before randomisation.”
Tranexamic acid (Chengdu Lier Pharmaceutical) and placebo (Hebei Tiancheng Pharmaceutical) are named with formulation (1g/10mL) and dose regimen. The primary analysis software (R version 4.4.3) is stated. Other resource categories (antibodies, cell lines, mycoplasma, organisms) are not applicable. The two applicable criteria are both adequate.
“All statistical analyses were performed using R version 4.4.3.”
“tranexamic acid (Chengdu Lier Pharmaceutical, Dujiangyan, Sichuan, China) and placebo (Hebei Tiancheng Pharmaceutical, Cangzhou, Hebei, China)”
“All statistical analyses were performed using R version 4.4.3.”
All applicable sub-criteria are adequate. Tests are named (log-binomial mixed effects, modified Poisson, linear mixed effects). Assumptions are addressed by the study design (mixed models). Exact p-values are reported for the primary outcome (P=0.01), and effect sizes with CIs are provided throughout. Software is identified. Data presentation includes per-group n, percentages, and CIs. Mathematical plausibility checks are satisfied (percentages sum correctly, no obvious impossibilities).
“relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01”
“All statistical analyses were performed using R version 4.4.3.”
“For binary outcomes, we used log-binomial mixed effects regression models with study centre as a random effect, adjusting for maternal age group and placenta praevia type, to estimate relative risks with 95% confidence intervals (CIs)”
“relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01”
“All statistical analyses were performed using R version 4.4.3.”
The data availability statement provides a GitHub URL (https://github.com/ChenDunjin-GZHMU) and mentions code in the supplementary file. GitHub is not a persistent repository with a DOI, so repository_deposit and code_sharing are rated as reported_but_inadequate. Accession numbers are not applicable (no sequencing data).
“The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU .”
“The code used to analyse the data in the paper are in the supplementary file.”
“The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU .”
“The code used to analyse the data in the paper are in the supplementary file.”
Methods are comprehensive for replication. Trial registration is provided (NCT05811676). All pre-specified outcomes are reported with negative results transparently. Limitations are discussed in a dedicated section. Conclusions are proportional to the evidence. Funding and competing interests are disclosed. The absence of a reporting guideline statement is a minor omission, but ≥60% of applicable criteria are adequate (6/7 = 86%), so pass.
“Trial registration ClinicalTrials.gov NCT05811676 .”
“The main limitation of this study was that, despite intending to systematically record all ineligible women and reasons for exclusion, comprehensive data collection was not feasible owing to practical constraints during the trial.”
“Trial registration ClinicalTrials.gov NCT05811676 .”
“The main limitation of this study was that, despite intending to systematically record all ineligible women and reasons for exclusion, comprehensive data collection was not feasible owing to practical constraints during the trial.”
“Funding: This work was supported by the National Key Research and Development Program of China (grant No 2022YFC2704500 and 2022YFC2704501)”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
1 finding · worst lowReferences 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.
- References not resolvable to a published paperRecomputed
Checked 26 references by DOI: 23 verified — 1 DOI unresolved, 1 no DOI (shown, not verified), 1 lookup failed.
- UNRESOLVED10.3760/cma.j.issn.0529-567x.2020.01.002[Guidelines for the diagnosis and management of placenta previa (2020)]Cited DOI does not resolve to any Crossref record.
- NO DOIA Roadmap to combat postpartum haemorrhage between 2023 and 2030No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NOT CHECKED10.1097/fm9.0000000000000297TRAPP- Protocol for TRanexamic Acid for the prevention of Postpartum hemorrhage in pregnant women with placenta Previa[crossref] rate_limited 429 https://api.crossref.org/works/10.1097%2Ffm9.0000000000000297?mailto=editorial%40alpha1science.com: HTTP 429
2 data/code links checked; 2 live.
- codeGitHubLIVEHTTP 200https://github.com/ChenDunjin-GZHMUResolves to GitHub (code repository).
- datahttps://public.flourish.studio/visualisation/28574562/LIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
7 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 7 minor suggestions below.
7 copyedit issues flagged: mostly grammar, consistency, clarity.
- MINORgrammarEthics statements“The trial was approved the Clinical Research and Applied Ethics Committee...”→ Add 'by': 'The trial was approved by the Clinical Research and Applied Ethics Committee...'Missing preposition.
- MINORgrammarData availability statement“The code used to analyse the data in the paper are in the supplementary file.”→ Change 'are' to 'is': 'The code... is in the supplementary file.'Subject-verb agreement; 'code' is singular.
- MINORconsistencyData availability statement“The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU .”→ Specify the exact repository (e.g., a specific GitHub repository) rather than a user profile URL, or deposit in a data repository with a DOI.The URL points to a GitHub user page, not a specific repository, which may not be findable over time.
- MINORclarityMethods, Statistical analysis“When these models failed to converge, we estimated adjusted relative risks using a modified Poisson regression model with generalised estimating equations, clustering by study centre and using robust sandwich standard errors.”→ Consider adding a brief justification for why non-convergence might occur.This is clear but could be slightly more explanatory.
- MINORgrammarEthics statements“The trial was approved the Clinical Research and Applied Ethics Committee”→ The trial was approved by the Clinical Research and Applied Ethics CommitteeMissing preposition 'by'.
- MINORgrammarData availability statement“The code used to analyse the data in the paper are in the supplementary file.”→ The code used to analyse the data in the paper is in the supplementary file.Subject-verb agreement: 'code' is singular.
- MINORgrammarTransparency paragraph“The corresponding author (DJC) affirm that the manuscript is an honest, accurate, and transparent account”→ The corresponding author (DJC) affirms that the manuscript is an honest, accurate, and transparent accountSubject-verb agreement: 'corresponding author' is singular.
As a published work, the trial is robust in design and reporting and its headline conclusions are supported by the reported evidence; an informed reader should weigh the minor reporting gaps (missing Helsinki statement, non-persistent data deposit, no CONSORT checklist) and the one unresolved reference. These are reporting/completeness issues that would warrant a correction or added documentation rather than undermining the trial's internal validity; independent re-analysis is not triggered by the 2/2 consistent recomputed statistics.
- 1.HIGHotherVerify or correct the reference '[Guidelines for the diagnosis and management of placenta previa (2020)]' (DOI 10.3760/cma.j.issn.0529-567x.2020.01.002), which could not be found in any registry.An unresolved reference is a fabrication signal and must be confirmed or corrected before the paper can be trusted.
- 2.HIGHethicsAdd an explicit regulatory-compliance statement to the Ethics statements section, e.g. 'The study was conducted in accordance with the Declaration of Helsinki' or 'ICH-GCP guidelines'.Both reviewers flagged the missing regulatory-framework statement as the reason ethical_approvals is a warn.
- 3.HIGHdata codeDeposit the de-identified dataset in a persistent repository with a DOI (e.g., Dryad, Zenodo, Figshare) and cite the accession number in the data availability statement, replacing the GitHub user-profile URL.The current GitHub user-page URL is not a persistent, findable archive and the copyedit noted it may not remain accessible.
- 4.HIGHdata codeArchive the analysis code with a permanent identifier (e.g., a GitHub release archived via Zenodo) and provide the DOI in the data availability statement.Supplementary-file code without a permanent identifier cannot be reliably located or versioned, and Reviewer 2 rated code sharing inadequate.
- 5.HIGHreportingReference the CONSORT 2010 reporting guidelines and provide a completed CONSORT checklist as supplementary material.Both reviewers noted the absence of a reporting-guideline statement; a CONSORT checklist strengthens transparency for a published RCT.
- 6.MEDIUMotherAdd a sentence in the Methods or Discussion explicitly justifying the single-sex study population (e.g., 'The study was restricted to women because placenta praevia occurs exclusively in pregnancy').Reviewer 2 noted the single-sex population is not explicitly justified, and Reviewer 1 noted race/ethnicity is not reported.
- 7.MEDIUMcopyeditFix the missing preposition in the Ethics statements section: 'was approved the Committee' → 'was approved by the Committee'.Grammar error flagged by both the copyedit pass and Reviewer 1.
- 8.MEDIUMcopyeditFix the subject-verb agreement in the Data availability statement: 'The code ... are in the supplementary file' → 'The code ... is in the supplementary file'.Grammar error flagged by the copyedit pass and Reviewer 1.
- 9.MEDIUMcopyeditFix the subject-verb agreement in the transparency paragraph: 'The corresponding author (DJC) affirm' → 'The corresponding author (DJC) affirms'.Grammar error flagged by the copyedit pass.
- 10.LOWreportingAdd a brief note in the Statistical analysis methods explaining why the log-binomial models might fail to converge and justify the modified Poisson fallback.The copyedit pass suggested this would improve clarity of the analysis plan.
- 11.LOWreportingClarify the blinding of outcome assessors during data collection and adjudication in the masking section.Reviewer 1 suggested adding detail on whether outcome assessors were blinded to group assignment.
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.