Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.
Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX
- DOI
- 10.1136/bmj-2023-078218
- Record issued
- 2026-08-16
- Engine
- 7.39.0
- Exported
- 2026-09-22
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/b3d6c4ed-90f1-4bd0-b35d-5d49fb747d92 is authoritative.
How this rating was calculated
- CitationsCitations & links (capped) ×5−1★
- IntegrityIntegrity concern−0.5★
- ClaimsOverstated claim−0.5★
- ReportingData & code availability partially met−0.25★
Citations & links are capped at −1★ combined, however many are flagged.
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 8 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.
- No data or code availability links were detected to verify.
- 01Cites retracted work
Retraction
“A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean Section”
Reference 23Find in source - 02Cites retracted work
Marked retracted/withdrawn in the Crossref title.
“Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery: A Randomized Clinical Trial”
Reference 52Find in source - 03Conclusion reaches beyond the evidence
The antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression.
“The antidepressant effect of low dose esketamine thus seems to last longer in mothers with prenatal depression than in the general population with depression.”
Discussion ¶1Find in source
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-designed and rigorously reported randomized controlled trial of low-dose esketamine for postpartum depression prevention. The main methodological strengths are the robust randomization, blinding, sample size calculation, and transparent reporting. The primary weakness is the vague and incomplete data availability statement, which limits reproducibility.
Both reviewers independently scored all eight dimensions and agreed on every status, so no divergence needed reconciliation. The statistics verification recomputed only a subset of tests (6 reported with test statistics/CI) and found them consistent; this does not confirm the correctness of all analyses. The citation check flagged 2 retracted and 3 not-found references, which are addressed in the action items.
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 6 tests: 6 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 3 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Recomputed relative risk 0.26 (95% CI 0.14–0.48), reported p<0.001
“relative risk 0.26, 95% confidence interval (CI) 0.14 to 0.48; P<0.001”
Taken as given: 0.14–0.48 is a two-sided 95% confidence interval for the relative risk of 0.26, not a range, an IQR, or a different interval level; the relative risk 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(0.26, 0.14, 0.48, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed relative risk 0.30 (95% CI 0.17–0.53), reported p<0.001
“relative risk 0.30, 95% CI 0.17 to 0.53; P<0.001”
Taken as given: 0.17–0.53 is a two-sided 95% confidence interval for the relative risk of 0.30, not a range, an IQR, or a different interval level; the relative risk 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(0.3, 0.17, 0.53, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed relative risk 1.49 (95% CI 1.29–1.71), reported p<0.001
“relative risk 1.49, 95% CI 1.29 to 1.71; P<0.001”
Taken as given: 1.29–1.71 is a two-sided 95% confidence interval for the relative risk of 1.49, not a range, an IQR, or a different interval level; the relative risk 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(1.49, 1.29, 1.71, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2Primary endpoint: major depressive episode at 42 days (esketamine vs placebo) using chi-square test.
“At 42 days post partum, a major depressive episode was observed in 6.7% (12/180) of participants in the esketamine group compared with 25.4% (46/181) in the placebo group (relative risk 0.26, 95% confidence interval (CI) 0.14 to 0.48; P<0.001).”
Taken as given: The numbers 12 and 46 are the event counts in the esketamine and placebo groups, respectively.; The denominators 180 and 181 are the group totals for the primary analysis.; The test used is Pearson's chi-square test without continuity correction.Method: Recomputed two-tailed p-value from the 2x2 table using Pearson's chi-square test.How we recomputed it: pChi2x2(12, 168, 46, 135) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2Primary endpoint after imputation: major depressive episode at 42 days (esketamine vs placebo) using chi-square test.
“After missing data had been imputed, major depressive episodes occurred in 7.7% (14/182) of participants in the esketamine group compared with 25.3% (46/182) in the placebo group (relative risk 0.30, 95% CI 0.17 to 0.53; P<0.001; ).”
Taken as given: The numbers 14 and 46 are the event counts in the esketamine and placebo groups, respectively.; The denominators 182 and 182 are the group totals for the imputed analysis.; The test used is Pearson's chi-square test without continuity correction.Method: Recomputed two-tailed p-value from the 2x2 table using Pearson's chi-square test.How we recomputed it: pChi2x2(14, 168, 46, 136) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Neuropsychiatric adverse events during and within 1 hour: esketamine vs placebo using chi-square test.
“had more neuropsychiatric symptoms (33.5% (61/182) v 11.0% (20/182); P<0.001)”
Taken as given: The numbers 61 and 20 are the event counts in the esketamine and placebo groups, respectively.; The denominators are both 182.; The test used is Pearson's chi-square test without continuity correction.Method: Recomputed two-tailed p-value from the 2x2 table using Pearson's chi-square test.How we recomputed it: pChi2x2(61, 121, 20, 162)
- lowinternal contradictionThe abstract reports overall neuropsychiatric adverse events as 45.1% (82/182) vs 22.0% (40/182), but the text in the safety outcomes section reports 33.5% (61/182) vs 11.0% (20/182) for 'neuropsychiatric symptoms' during and within 1 hour. The abstract's numbers likely represent a broader definition (including all time points), but the discrepancy is not explicitly explained.
“The overall incidence of neuropsychiatric adverse events was higher in the esketamine group (45.1% (82/182) v 22.0% (40/182); P<0.001).”
AbstractFind in source
Overstated conclusions
1 finding · worst mediumConclusions 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 overstated beyond the evidenceAssessed
6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).
- overstatedReviewers 1, 2The antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression.The claim is speculative and not directly supported by the data; the study only followed up to 42 days and did not compare with a general depression population.Evidence: The paper states 'The antidepressant effect of low dose esketamine thus seems to last longer in mothers with prenatal depression than in the general population with depression.' but provides no comparative data.
“The antidepressant effect of low dose esketamine thus seems to last longer in mothers with prenatal depression than in the general population with depression.”
Discussion ¶1Find in source - supportedReviewers 1, 2A single low dose of esketamine after childbirth reduces major depressive episodes at 42 days post partum by about three quarters in mothers with prenatal depression.The primary endpoint result (RR 0.26, 95% CI 0.14-0.48) directly supports this claim.Evidence: Primary endpoint: 6.7% vs 25.4%, RR 0.26 (95% CI 0.14-0.48), P<0.001.
“For mothers with prenatal depression, a single low dose of esketamine after childbirth decreases major depressive episodes at 42 days post partum by about three quarters.”
ConclusionFind in source - supportedReviewer 1Neuropsychiatric symptoms were more frequent but transient and did not require drug intervention.The safety data show higher incidence of neuropsychiatric symptoms in the esketamine group, but they resolved without drug treatment.Evidence: Safety outcomes: neuropsychiatric symptoms 33.5% vs 11.0% during infusion, but no severe adverse events and no midazolam required.
“Neuropsychiatric symptoms were more frequent but transient and did not require drug intervention.”
ConclusionFind in source - supportedReviewer 2Esketamine reduces Edinburgh postnatal depression scale scores at 7 and 42 days post partum.Median differences were -3 (95% CI -4 to -2) at both time points, with P<0.001, supporting the claim.Evidence: Secondary outcomes: median difference -3 (95% CI -4 to -2) at 7 and 42 days, P<0.001.
“Edinburgh postnatal depression scale scores were lower in the esketamine group at seven days (median difference −3, 95% CI −4 to −2; P<0.001) and 42 days (−3, −4 to −2; P<0.001).”
AbstractFind in source - supportedReviewer 2Esketamine reduces Hamilton depression rating scale scores at 42 days post partum.Median difference was -4 (95% CI -6 to -3) with P<0.001, supporting the claim.Evidence: Secondary outcome: median difference -4 (95% CI -6 to -3), P<0.001.
“Hamilton depression rating scale scores at 42 days post partum were also lower in the esketamine group (−4, −6 to −3; P<0.001).”
AbstractFind in source - supportedReviewer 2Neuropsychiatric adverse events are more frequent with esketamine but transient and do not require drug treatment.The incidence was higher (45.1% vs 22.0%), but symptoms lasted less than a day and none required drug treatment, as reported.Evidence: Safety outcomes: overall neuropsychiatric adverse events 45.1% vs 22.0%, P<0.001; symptoms transient, no drug treatment needed.
“The overall incidence of neuropsychiatric adverse events was higher in the esketamine group (45.1% (82/182) v 22.0% (40/182); P<0.001); however, symptoms lasted less than a day and none required drug treatment.”
AbstractFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary endpoint is a major depressive episode at 42 days post partum, diagnosed using the mini-international neuropsychiatric interview, which is a validated diagnostic interview for depression, a hard clinical outcome. Secondary endpoints include validated depression scales (EPDS, HAMD-17). The efficacy claim is based on this clinical diagnosis, not a surrogate biomarker.
“The primary outcome was prevalence of a major depressive episode at 42 days post partum, diagnosed using the mini-international neuropsychiatric interview.”
- ADEQUATEEffect sizeThe primary outcome shows a relative risk of 0.26 (95% CI 0.14 to 0.48) for major depressive episode at 42 days, corresponding to a reduction from 25.4% to 6.7%, with a number needed to treat of 5. This is a large, clinically meaningful effect on a hard clinical endpoint, and the confidence interval excludes the null.
“At 42 days post partum, a major depressive episode was observed in 6.7% (12/180) of participants in the esketamine group compared with 25.4% (46/181) in the placebo group (relative risk 0.26, 95% confidence interval (CI) 0.14 to 0.48; P<0.001).”
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
1 finding · 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
Prior work is cited on perinatal depression prevalence, consequences, and the antidepressant effects of ketamine/esketamine. The authors note that previous trials were largely restricted to caesarean delivery and excluded mothers with depression, providing a clear gap. The hypothesis follows logically from the cited evidence.
“Depression is common among women during the perinatal period, with a reported prevalence of 6-13% in high income countries, 21% in middle income countries, and 26% in low income countries.”
“However, previous trials were largely restricted to caesarean delivery and excluded mothers with depression and thus at high risk of postpartum depression.”
“We therefore tested the primary hypothesis that a single low dose of esketamine given shortly after delivery reduces depression over 42 days among mothers with prenatal depression.”
“However, previous trials were largely restricted to caesarean delivery and excluded mothers with depression and thus at high risk of postpartum depression.”
“We therefore tested the primary hypothesis that a single low dose of esketamine given shortly after delivery reduces depression over 42 days among mothers with prenatal depression.”
“Importantly, our trial extends existing understanding by targeting women with pre-existing prenatal depression, who were therefore at high risk of postnatal depression.”
Randomization was computer-generated with stratification by site and block size, and allocation was concealed using opaque envelopes. Blinding of participants, healthcare team, and outcome assessors is described. A priori sample size calculation is provided with assumptions. Inclusion/exclusion criteria are clearly defined. The analysis population (ITT and per-protocol) and missing data handling are specified.
“An independent biostatistician generated random treatment assignments in a 1:1 ratio, stratified by trial site, with a block size of four using the PROC PLAN procedure of SAS 9.2 software (SAS Institute, Cary, NC).”
“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”
“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference.”
“An independent biostatistician generated random treatment assignments in a 1:1 ratio, stratified by trial site, with a block size of four using the PROC PLAN procedure of SAS 9.2 software (SAS Institute, Cary, NC). Allocations were sealed in sequentially numbered opaque envelopes controlled by investigators who were otherwise not involved in data acquisition or the participants’ care.”
“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”
“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference. We expected a dropout rate of about 10% and thus planned to enrol a total of 364 participants.”
The study reports age, BMI, education, employment, income, and baseline EPDS scores in Table 1. Sex is inherently female (pregnant mothers), and both sexes are not applicable. Age and health status are reported. Demographics are comprehensive.
“Mean (SD) age (years) | 31.8 (4.0) | 31.7 (4.1)”
“Median (IQR) Edinburgh postnatal depression scale‡‡ | 10 (10 to 12) | 10 (10 to 12)”
“The mean age of enrolled participants was 31.8 (SD 4.1) years.”
“We enrolled pregnant individuals aged 18 years or older with an Edinburgh postnatal depression scale score of ≥10 who were close to childbirth.”
The protocol was approved by the Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other centres. Written informed consent was obtained from each participant. The trial was registered at ClinicalTrials.gov.
“The Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other participating centres approved the study protocol (see supplement 1).”
“Written informed consent was obtained from each participant.”
“The Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other participating centres approved the study protocol (see supplement 1).”
“Written informed consent was obtained from each participant.”
“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”
Esketamine is identified as the drug, with dose (0.2 mg/kg) and route (IV infusion over 40 minutes). The placebo is normal saline. Statistical software (SPSS 25.0, SAS 9.2) is identified. No antibodies, cell lines, or other bench reagents are used, so those criteria are not applicable.
“Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.”
“Statistical analyses were performed with the SPSS 25.0 software (IBM SPSS, Chicago, IL).”
“Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.”
“Statistical analyses were performed with the SPSS 25.0 software (IBM SPSS, Chicago, IL).”
The primary endpoint was compared using chi-square test with relative risk and 95% CI. Secondary continuous variables used t-test or Mann-Whitney with median differences and Hodges-Lehmann CIs. Exact p-values are reported (e.g., P<0.001). Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks are not applicable for large-N continuous outcomes.
“The prevalence of a major depressive episode at 42 days post partum, our primary endpoint, was compared with a χ 2 test, with differences between groups expressed as relative risk and 95% confidence interval (CI).”
“relative risk 0.26, 95% CI 0.14 to 0.48; P<0.001”
“The prevalence of a major depressive episode at 42 days post partum, our primary endpoint, was compared with a χ 2 test, with differences between groups expressed as relative risk and 95% confidence interval (CI).”
“relative risk 0.26, 95% CI 0.14 to 0.48; P<0.001”
“Edinburgh postnatal depression scale scores were lower in the esketamine group at seven days (median difference −3, 95% CI −4 to −2; P<0.001)”
The statement says anonymised individual patient data can be made available to researchers who provide a sound proposal, but does not specify a platform, committee, or conditions. This is reported_but_inadequate. No code is shared, but no bespoke code is mentioned.
“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”
“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”
Trial registration number is provided (NCT04414943). CONSORT guidelines are mentioned. All pre-specified outcomes are reported in tables. Limitations are explicitly discussed. Funding sources and competing interests are declared.
“Trial registration ClinicalTrials.gov NCT04414943 .”
“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”
“An important limitation is that we excluded mothers with prepregnancy mood disorders (three mothers were excluded for depression or anxiety), and thus failed to include participants in greatest need of intervention.”
“Trial registration ClinicalTrials.gov NCT04414943 .”
“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”
“An important limitation is that we excluded mothers with prepregnancy mood disorders (three mothers were excluded for depression or anxiety), and thus failed to include participants in greatest need of intervention.”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
2 findings · worst highReferences 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.
- Cites retracted workRecomputed
- References not resolvable to a published paperRecomputed
Checked 62 references by DOI: 54 verified — 2 retracted, 3 DOI unresolved, 3 no DOI (shown, not verified).
- RETRACTED10.1155/2022/1524198A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean SectionReason: Retraction
- RETRACTED10.1001/jamanetworkopen.2023.9321Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery: A Randomized Clinical TrialReason: Marked retracted/withdrawn in the Crossref title.
- UNRESOLVED10.3969/j.issn.1000-6729.2012.09.007Differential validity of SAS and SDS among psychiatric non-psychotic outpatients and their partnersCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.3969/j.issn.1009-5551.2008.01.001Investigation of reliability and validity of the social support scaleCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.3969/j.issn.1005-3611.2004.03.002The Chinese Marital Quality Inventory: Development, Reliability and ValidityCited DOI does not resolve to any Crossref record.
- NO DOIThe Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIEvaluation of the Reliability and Validity of Chinese version of the MINI-International Neuropsychiatric Interview in Patients with Mental DisordersNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIA theoretical research and practical application of Social Support Rating ScaleNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
Copyediting
4 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 4 minor suggestions below.
4 copyedit issues flagged: mostly clarity, consistency, other.
- MINORconsistencyAbstract, Results“45.1% (82/182) v 22.0% (40/182)”→ Use 'vs' instead of 'v' for consistency with the rest of the text.The abbreviation 'v' is used in the abstract but 'vs' is used elsewhere.
- MINORclarityMethods, Statistical analysis“As the proportion of participants with missing data was <5%, we assigned best outcome to participants in the placebo group and worst outcome to participants in the esketamine group.”→ Clarify that this is a post hoc sensitivity analysis and specify the direction of imputation for each group.The sentence is clear but could be more explicit about the imputation direction.
- MINORclarityData availability statement“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”→ Complete the sentence with the specific conditions and contact information.The sentence is cut off and incomplete.
- MINORotherTable 2, footnote“Merged to avoid identifiability.”→ Clarify which categories were merged and why.The footnote is vague; it would be helpful to specify the merged categories.
The published work is methodologically robust and generally well-reported, but an informed reader should weigh the incomplete data availability statement, the presence of retracted citations, and one overstated claim in the discussion. These issues do not invalidate the core findings but warrant attention; a correction or clarification from the authors would strengthen the record.
- 1.HIGHdata codeComplete the data availability statement in the 'Data availability statement' section by specifying a concrete access mechanism (e.g., a data access committee, a repository like Vivli or YODA, or a contact with conditions and timeframe).The current statement is cut off and vague, failing to meet reproducibility standards for a data-driven clinical trial.
- 2.HIGHreportingRemove or replace the two retracted citations: 'A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean Section' (doi:10.1155/2022/1524198) and 'Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery' (doi:10.1001/jamanetworkopen.2023.9321).Citing retracted works undermines the integrity of the reference list and could mislead readers.
- 3.HIGHreportingVerify or correct the three references not found in any registry: 'Differential validity of SAS and SDS among psychiatric non-psychotic outpatients and their partners' (doi:10.3969/j.issn.1000-6729.2012.09.007), 'Investigation of reliability and validity of the social support scale' (doi:10.3969/j.issn.1009-5551.2008.01.001), and 'The Chinese Marital Quality Inventory: Development, Reliability and Validity' (doi:10.3969/j.issn.1005-3611.2004.03.002).References that cannot be located in any registry may be fabricated or contain incorrect DOIs, which is a serious integrity concern.
- 4.HIGHrigorTemper the claim in the Discussion that 'the antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression' to reflect that the study only followed up to 42 days and did not directly compare with a general depression population.The claim is overstated and not directly supported by the data, which is a common reviewer objection.
- 5.MEDIUMreportingClarify the discrepancy between the abstract's overall neuropsychiatric adverse events (45.1% vs 22.0%) and the safety outcomes section's 'neuropsychiatric symptoms' (33.5% vs 11.0%) by explaining the different definitions or time windows.The internal contradiction may confuse readers and could be flagged as an inconsistency.
- 6.MEDIUMcopyeditChange 'v' to 'vs' in the Abstract Results section for consistency with the rest of the text.Inconsistent abbreviation usage is a minor copyedit issue that should be fixed for professionalism.
- 7.MEDIUMcopyeditClarify the sensitivity analysis in Methods, Statistical analysis by specifying that it is a post hoc analysis and explicitly stating the direction of imputation for each group.The current description is clear but could be more explicit to avoid misinterpretation.
- 8.MEDIUMcopyeditClarify the Table 2 footnote 'Merged to avoid identifiability' by specifying which categories were merged and why.The vague footnote reduces transparency about data handling.
- 9.LOWdata codeConsider depositing de-identified aggregate data or statistical analysis code in a public repository (e.g., Zenodo) with a DOI to enhance reproducibility.While not mandatory, sharing code and aggregate data would strengthen the reproducibility of the trial.
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.