Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.
Perslev K, Klarskov N, Bergholt T, Jangö H
- DOI
- 10.1136/bmj-2025-084312
- 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/6a172b5c-31d7-45aa-b603-ff31262bb27c is authoritative.
How this rating was calculated
- IntegrityIntegrity concern−0.5★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary efficacy claim is based on a surrogate outcome: 'clinically relevant wound complications' defined by wound dehiscence size, pain, or infection, which is a clinical assessment but not a hard clinical outcome like mortality or a validated functional scale. The paper does not provide evidence that this surrogate is validated as a reliable predictor of long-term clinical outcomes, nor does it demonstrate target engagement (e.g., PK/PD) at the tested dose. The primary outcome (wound complications) was non-significant, and the secondary outcome was added post hoc, further weakening the surrogate's validity.
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01)... The outcome was included in the REDCap database before initiation of the study... and updated in ClinicalTrials.gov…”
- 02Treatment effect not shown to be clinically meaningful
The reported effect for the secondary outcome is a reduction from 17% to 9% (relative risk 0.52), but the paper does not anchor this to a minimal clinically important difference or demonstrate that this magnitude is clinically meaningful. The primary outcome showed no significant effect, and the secondary outcome was not prespecified as the primary endpoint. The number needed to treat of 12 is presented without a clear clinical threshold for meaningfulness.
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88).”
- 03Other integrity concern
Trial NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21. 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.
NCT05830162
reviewer’s wording
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 RCT with rigorous design, clear ethical approvals, and open data/code. The main weaknesses are minor reporting gaps (e.g., timing of antibiotic administration not recorded, retrospective registration) and a few copyedit issues.
Both reviewers classified the study as interventional (RCT) and agreed on all dimensions. The statistics verification recomputed only 2 tests (those with test statistics/df or effect estimates with CIs); exact p-values from Fisher's test were not machine-verified. The citation check found no retracted or unresolved references. The integrity check flagged retrospective registration, which is noted in reporting transparency.
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 = .100 · recomputed p = .097Reviewers 1, 2Primary outcome comparison (wound complications) using Fisher's exact test
“Wound complications* | 47 (21.6) | 62 (28.8) | 0.10”
Taken as given: The numbers 47 and 62 are the event counts in the antibiotic and placebo groups, respectively.; The group totals are 218 and 215, so non-events are 171 and 153.; The test used is Fisher's exact test (two-tailed) as stated in the methods.Method: Fisher's exact test (two-tailed) on the 2x2 table (47,171,62,153).How we recomputed it: pFisher2x2(47, 171, 62, 153, 0) - CONSISTENTreported p = .010 · recomputed p = .014Reviewers 1, 2Secondary outcome comparison (clinically relevant wound complications) using Fisher's exact test
“Clinically relevant wound complications† | 19 (8.7) | 36 (16.7) | 0.01”
Taken as given: The numbers 19 and 36 are the event counts in the antibiotic and placebo groups, respectively.; The group totals are 218 and 215, so non-events are 199 and 179.; The test used is Fisher's exact test (two-tailed) as stated in the methods.Method: Fisher's exact test (two-tailed) on the 2x2 table (19,199,36,179).How we recomputed it: pFisher2x2(19, 199, 36, 179, 0)
Overstated conclusions
3 findings · worst highConclusions 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
5 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.
- partialReviewers 1, 2The findings provide evidence to support updating postpartum care guidelines.The study provides evidence for a reduction in clinically relevant wound complications, but the claim of updating guidelines is a broader recommendation that may require further replication and consideration of generalisability.Evidence: The secondary outcome result and the discussion of implications.
The findings provide evidence to support updating postpartum care guidelines to reduce the risk of clinically relevant wound complications for women with episiotomy or second degree tear.
What this study addsreviewer’s wording - supportedReviewers 1, 2Prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications.The claim is directly supported by the secondary outcome result (19/218 vs 36/215, P=0.01, RR 0.52).Evidence: Secondary outcome result in Table 2 and Abstract.
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88).”
AbstractFind in source - supportedReviewer 1No significant effect was seen for overall wound complications.The primary outcome result (47/218 vs 62/215, P=0.10) supports the claim of no significant difference.Evidence: Primary outcome result in Table 2 and Abstract.
“No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10), with a risk difference of −7.2% (95% confidence interval (CI) −15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04).”
AbstractFind in source - supportedReviewers 1, 2The protective effect of prophylactic antibiotics is also significant in low risk populations.The post hoc subgroup analysis of women without high-risk variables showed consistent significant effects, as stated in the results.Evidence: Post hoc subgroup analysis described in Results and supplementary file S4.
“Post hoc subgroup analysis of women without high risk variables (body mass index ≥30, instrumental delivery, or episiotomy) showed a consistently significant effect (P<0.05 in all three subanalyses) of antibiotics regarding clinically relevant wound complications (supplementary file S4).”
ResultsFind in source - supportedReviewer 2No significant difference was observed in overall wound complications.The primary outcome showed a non-significant difference (P=0.10), consistent with the claim.Evidence: Primary outcome: 47/218 (21.6%) vs 62/215 (28.8%), P=0.10.
“No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10)”
AbstractFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary efficacy claim is based on a surrogate outcome: 'clinically relevant wound complications' defined by wound dehiscence size, pain, or infection, which is a clinical assessment but not a hard clinical outcome like mortality or a validated functional scale. The paper does not provide evidence that this surrogate is validated as a reliable predictor of long-term clinical outcomes, nor does it demonstrate target engagement (e.g., PK/PD) at the tested dose. The primary outcome (wound complications) was non-significant, and the secondary outcome was added post hoc, further weakening the surrogate's validity.
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01)... The outcome was included in the REDCap database before initiation of the study... and updated in ClinicalTrials.gov before completion and unblinding.”
- INADEQUATEEffect sizeThe reported effect for the secondary outcome is a reduction from 17% to 9% (relative risk 0.52), but the paper does not anchor this to a minimal clinically important difference or demonstrate that this magnitude is clinically meaningful. The primary outcome showed no significant effect, and the secondary outcome was not prespecified as the primary endpoint. The number needed to treat of 12 is presented without a clear clinical threshold for meaningfulness.
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88).”
Data authenticity concerns
1 finding · worst mediumAn 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
1 integrity concern flagged (0 high).
- mediumotherTrial NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21. 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.
NCT05830162
reviewer’s wording
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 paper cites a Cochrane review on prophylactic antibiotics for obstetric anal sphincter injury and a 2017 Cochrane review on episiotomy, noting methodological limitations and insufficient evidence. It also references the ANODE trial and WHO recommendations, building a rationale for the study. The premise is well-supported by the cited evidence, and limitations of prior studies (e.g., high loss to follow-up, lack of placebo control) are explicitly acknowledged.
“A Cochrane review evaluated prophylactic antibiotics for obstetric anal sphincter injury, but included only one randomised controlled trial, which reported a reduction in healing complications from 24% to 8% following a single intravenous dose of antibiotics. The loss to follow-up was high, prompting the authors to recommend cautious data interpretation.”
“Even less data are available on the effect of prophylactic antibiotics after the most common obstetric tears: episiotomies and second degree tears.”
“One trial did not define wound dehiscence, and the other trial was not placebo controlled. Both studies had very low infection numbers.”
“A Cochrane review evaluated prophylactic antibiotics for obstetric anal sphincter injury, but included only one randomised controlled trial, which reported a reduction in healing complications from 24% to 8% following a single intravenous dose of antibiotics. The loss to follow-up was high, prompting the authors to recommend cautious data interpretation.”
“Even less data are available on the effect of prophylactic antibiotics after the most common obstetric tears: episiotomies and second degree tears.”
“A 2017 Cochrane review evaluated antibiotic use after episiotomy but included only one study with methodological limitations. The review concluded that evidence was not sufficient to recommend prophylactic antibiotic use.”
Randomization was computer-generated with variable block sizes, and blinding was maintained for participants, physicians, and the steering committee. A priori sample size calculation was performed with a stated effect size, alpha, and power. Inclusion/exclusion criteria were pre-specified. The analysis population (ITT) and missing-data handling (extreme case scenarios) are described. The trial is a human RCT, so replicate_distinction, controls, and independent_replication are not applicable.
“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”
“Randomisation therefore occurred before enrolment and remained blinded to the staff (except repacking individuals), the steering committee (comprising all authors), and the patients until unblinding.”
“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion, with a 1:1 allocation ratio.”
“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”
“Randomisation therefore occurred before enrolment and remained blinded to the staff (except repacking individuals), the steering committee (comprising all authors), and the patients until unblinding.”
“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion, with a 1:1 allocation ratio.”
The study reports sex (all female), age (mean and SD), BMI (median and IQR), and health status (e.g., gestational diabetes, pre-eclampsia). Demographics are reported in Table 1. Since the study includes both sexes (all female by design), sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial.
“In this study, “women” refers to people of female sex; all genders were eligible for inclusion.”
“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”
“Gestational diabetes mellitus | 0 | 9 (4.1) | 10 (4.7)”
“In this study, “women” refers to people of female sex; all genders were eligible for inclusion.”
“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”
“Primiparous women | 0 | 147 (67) | 144 (67)”
The trial was approved by the Danish Medicines Agency and the Danish National Committee on Health Research Ethics via the EU Clinical Trials Information System, with a protocol number. Written informed consent was obtained from all participants. Regulatory compliance is implied through the EU CTIS approval and adherence to Good Clinical Practice.
“The trial was approved in Denmark through the EU Clinical Trials Information System (CTIS; EU No 2022-501930-49-00) by the Danish Medicines Agency and the Danish National Committee on Health Research Ethics.”
“All participants provided written informed consent.”
“The trial was approved in Denmark through the EU Clinical Trials Information System (CTIS; EU No 2022-501930-49-00) by the Danish Medicines Agency and the Danish National Committee on Health Research Ethics.”
“All participants provided written informed consent.”
“the study was monitored by the national Danish Good Clinical Practice Unit.”
The drug is identified by name, dose, and regimen. The placebo is described as calcium tablets matching in size, shape, and colour. Statistical software (R Studio version 4.4.1) is identified. No antibodies, cell lines, or other biological resources are used, so those criteria are not applicable.
“The treatment group received three doses of oral antibiotics: amoxicillin (500 mg) with clavulanic acid (125 mg).”
“We used R Studio version 4.4.1 to perform statistical analyses.”
“The treatment group received three doses of oral antibiotics: amoxicillin (500 mg) with clavulanic acid (125 mg).”
“We used R Studio version 4.4.1 to perform statistical analyses.”
The paper names the statistical tests used (Fisher's exact test, t-test, Mann-Whitney U test) and reports exact p-values (e.g., P=0.10, P=0.01). Effect sizes with 95% CIs are provided for primary and secondary outcomes. Software is identified. Data presentation includes per-group n and percentages. Mathematical plausibility checks were not performed due to lack of raw data, but no obvious inconsistencies were noted.
“We used Fisher’s exact test for categorical variables while continuous variables were analysed using the t test when normally distributed and using the Mann-Whitney U test when not normally distributed.”
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88).”
“We used Fisher’s exact test for categorical variables while continuous variables were analysed using the t test when normally distributed and using the Mann-Whitney U test when not normally distributed.”
“Wound complications were non-significantly lower in the treatment group (22% v 29%, P=0.10), while clinically relevant wound complications were significantly reduced (9% v 17%, P=0.01; ).”
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88).”
The data availability statement provides a direct link to a public repository (Dataverse) with a DOI. The code is stated to be in supplemental files. This meets the criteria for data_availability_statement, repository_deposit, and code_sharing. Accession numbers are not applicable for this type of data.
“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD .”
“The code used to analyse the data in the paper can be found in the supplemental files.”
“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD .”
“The code used to analyse the data in the paper can be found in the supplemental files.”
The trial is registered in two registries with numbers. The paper adheres to CONSORT 2010 guidelines. Limitations are discussed in the Discussion section. Conclusions are proportional to the evidence, with appropriate caveats about exploratory outcomes. Funding and competing interests are declared.
“Trial registration Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162 (https://clinicaltrials.gov/ct2/show/NCT05830162) .”
“the present study adheres to the CONSORT 2010 guidelines.”
“Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”
“Trial registration Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162 (https://clinicaltrials.gov/ct2/show/NCT05830162) .”
“the present study adheres to the CONSORT 2010 guidelines.”
“Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”
Registered (1 ID: 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 22 references by DOI: 17 verified — 5 no DOI (shown, not verified).
- NO DOIClinical evaluation of the chloramphenicol use as a prophylactic antibiotic in the vaginal delivery with episiotomyNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICould subcutaneous rifampicin administration be an effective approach for reducing episiotomy infections?No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICDC/NHSN Surveillance Definitions for Specific Types of Infections: Surveillance DefinitionsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIRStudioNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOILactogenesis: The transition from pregnancy to lactation: Breastfeeding 2001, Part I: The evidence for breastfeedingNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- dataDataverseLIVEHTTP 200https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BDResolves to Dataverse (data repository).
Copyediting
6 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 6 minor suggestions below.
6 copyedit issues flagged: mostly consistency, clarity, typo.
- MINORconsistencyAbstract“The study ended as planned, in December 2024.”→ Consider moving this sentence to the Results section for clarity.The sentence appears in the Abstract but is more appropriate for Results.
- MINORclarityMethods, Outcome“The outcome was included in the REDCap database before initiation of the study (supplementary file S2) and updated in ClinicalTrials.gov before completion and unblinding.”→ Clarify that the secondary outcome was added to ClinicalTrials.gov after study initiation, as noted in the limitations.The sentence could be misinterpreted as the outcome being registered before initiation.
- MINORtypoTable 1“Occiput posterior | 11 (5.2) | 8 (3.9)”→ Add a header for the fetal presentation rows to align with the table format.The row for 'Occiput posterior' lacks a header, making it unclear which column is which.
- MINORconsistencyAbstract, Results“433 women completed follow-up and were included in the primary analysis.”→ Ensure consistency with the CONSORT flowchart and Results section.The number 433 is consistent with the Results section.
- MINORclarityMethods, Outcome“If wound dehiscence of more than 5 mm was observed, we secondarily categorised it as clinically relevant if it required clinical follow-up because of the extent of the dehiscence (typically ≥10 mm), severity of pain (typically visual analogue scale score ≥5 or patient reported affected daily life), or infection.”→ Consider simplifying the sentence for readability.The sentence is long but clear.
- MINORotherData availability statement“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD .”→ Remove the extra space before the period.Minor formatting issue.
The published work is robust and well-reported; an informed reader should weigh the retrospective registration and the lack of recorded timing of antibiotic administration as minor limitations. No erratum is warranted, but the authors should consider clarifying the registration timeline and the timing of drug administration in any future correspondence or data notes.
- 1.HIGHreportingIn the Discussion or a data note, explicitly acknowledge that the trial was registered retrospectively (first submitted to ClinicalTrials.gov on 2023-03-29, after the study start date of 2023-03-21) and explain the reason for the delay.Retrospective registration undermines the transparency that prospective registration is meant to provide; acknowledging it directly addresses a potential reviewer/reader concern.
- 2.HIGHreportingReport the exact timepoint of antibiotic administration relative to delivery, or explicitly state that this information was not recorded and discuss the potential impact on the primary outcome.The timing of prophylactic antibiotics is clinically relevant and its absence limits interpretation of efficacy.
- 3.MEDIUMreportingClarify the definition of 'clinically relevant wound dehiscence' with more objective criteria, as the current description relies on clinical judgment.A more objective definition would improve reproducibility and reduce subjectivity in outcome assessment.
- 4.MEDIUMreportingClarify in the Methods/Outcome section that the secondary outcome was added to ClinicalTrials.gov after study initiation, as noted in the limitations, to avoid misinterpretation.The current wording could be misread as the outcome being registered before initiation, which is a transparency issue.
- 5.MEDIUMreportingReport the results of the per-protocol analysis in the main text rather than only in supplementary files.Per-protocol results are important for assessing robustness of the ITT findings and are currently under-reported.
- 6.MEDIUMreportingProvide more detail on the blinding of the repacking individuals and how they were prevented from influencing outcomes.Clarifying the blinding of repacking staff strengthens confidence in the double-blind design.
- 7.MEDIUMreportingClarify the handling of missing data for baseline variables (e.g., BMI missing for 20 women) in the statistical analysis.Transparent missing-data handling is essential for reproducibility and to avoid bias.
- 8.MEDIUMreportingDiscuss the potential impact of the higher induction rate in the treatment group on the primary outcome.Baseline imbalance in a prognostic factor could confound the primary analysis and should be addressed.
- 9.LOWcopyeditMove the sentence 'The study ended as planned, in December 2024.' from the Abstract to the Results section.The sentence is more appropriate in Results than in the Abstract for clarity.
- 10.LOWcopyeditAdd a header for the fetal presentation rows in Table 1 to align with the table format.The row for 'Occiput posterior' lacks a header, making it unclear which column is which.
- 11.LOWcopyeditRemove the extra space before the period in the data availability statement URL.Minor formatting issue that should be corrected for professionalism.
- 12.LOWreportingAdd a note on the generalizability of the findings to non-Danish-speaking populations, as the study excluded them.The exclusion of non-Danish speakers limits generalizability and should be explicitly acknowledged.
- 13.LOWreportingConsider including a statement on data availability for the long-term follow-up results when they are published.Proactively stating future data availability supports transparency and reproducibility.
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.