Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial.
Parker CC, Clarke NW, Cook AD, Kynaston H, Catton CN, Cross WR, Petersen PM, Persad RA, Saad F, Bower LC, Logue J, Payne H, Forcat S, Goldstein C, Murphy C, Anderson J, Barkati M, Bottomley DM, Branagan J, Choudhury A, Chung PWM, Cogley L, Goh CL, Hoskin P, Khoo V, Malone SC, Masters L, Morris SL, Nabid A, Ong AD, Raman R, Tarver KL, Tree AC, Worlding J, Wylie JP, Zarkar AM, Parulekar WR, Parmar MKB, Sydes MR, RADICALS investigators
- DOI
- 10.1016/S0140-6736(24)00548-8
- Record issued
- 2026-08-10
- Engine
- 7.30.0
- Exported
- 2026-09-21
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/9f421833-bfc3-41cf-a4ed-7a8b8ef8b881 is authoritative.
How this rating was calculated
- ReportingEthical approvals partially met−0.25★
- ReportingKey resources partially met−0.25★
- CitationsUnresolved reference−0.25★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.
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.
The RADICALS-HD paper is a well-designed and transparently reported phase 3 RCT: centralised minimisation randomisation, pre-specified power analysis, intention-to-treat analyses, named statistical methods with effect sizes and confidence intervals, trial registration, and a concrete controlled-access data-sharing statement. The main weaknesses are documentation-level: a vague ethics-approval statement with no named committee or protocol number and no regulatory-compliance statement, investigational ADT drugs named without manufacturer/source, race/ethnicity not collected, no explicit reporting-guideline reference, and minor copyedit issues including threshold-only p-values and a possibly truncated data-sharing sentence. No statistical or factual errors were found in the machine-verifiable subset, and no retracted references were identified.
Post-publication audit synthesizing three independent runs of the same reviewer model (sampling stability, not independent corroboration), a copyedit pass, and machine verification components. Four reported statistics were recomputed consistently; threshold-only p-values and GRIM/GRIMMER checks were not machine-verifiable/applicable. One reference (RADICALS trial statistical analysis plan, DOI 10.5281/zenodo.6586525) was not found in any registry and needs verification; no retractions were found. Reviewers diverged on biological variables, key resources, and statistical analysis; synthesized statuses follow the ≥60%-adequate checklist rule with both positions preserved in the details.
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 4 tests: 4 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 3 via agent-written checks.
- CONSISTENTreported p = .350 · recomputed p = .347Recomputed HR 0.886 (95% CI 0.688–1.140), reported p=0.35
“HR 0.886 [95% CI 0.688–1.140], p=0.35”
Taken as given: 0.688–1.140 is a two-sided 95% confidence interval for the HR of 0.886, not a range, an IQR, or a different interval level; the HR is a RATIO measure, so the interval is symmetric on the log scale; p=0.35 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(0.886, 0.688, 1.14, 1) - CONSISTENTreported p = .350 · recomputed p = .347Reviewers 1, 2Primary metastasis-free survival HR and p-value from Cox model (approximated via CI).
“metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35).”
Taken as given: The HR is from a Cox model stratified by randomization factors; The 95% CI is two-sided and based on the normal approximation; The p-value is from the Wald test or log-rank test, approximated by the CI-based z-testMethod: Two-tailed p from log-HR and its SE derived from the CIHow we recomputed it: pCI(0.886, 0.688, 1.140, 1) - CONSISTENTreported p = .150 · recomputed p = .110Reviewers 1, 2, 3Chi-square test for grade 3 or higher toxicity (any toxicity).
“Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15)”
Taken as given: The test is a Pearson chi-square test of independence on a 2x2 table; The numbers 121 and 100 are the counts of events in each group; The non-event counts are 737-121=616 and 743-100=643Method: Two-tailed Pearson chi-square test for a 2x2 contingency tableHow we recomputed it: pChi2x2(121, 616, 100, 643) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Clinical progression-free survival: HR 0.544, 95% CI 0.433-0.684, log-rank p<0.0001.
“0·544 (0·433–0·684) | <0·0001”
Taken as given: The CI is a 95% confidence interval for a hazard ratio.; The hazard ratio and CI are from the same comparison.; The reported p is from a log-rank test and is two-sided.Method: Recomputed two-sided p from the log HR and CI; result is below 0.0001, consistent with the reported threshold.How we recomputed it: pCI(0.544,0.433,0.684,1)
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
7 major claims checked against the paper's own evidence: all adequately supported.
- partialReviewer 2Given the lack of improvement in metastasis-free survival, it is unlikely that short-course ADT will improve overall survival.The ICECaP surrogate argument is cited, and the MFS result is null, but the claim is an inference about long-term OS, which is reasonable but not directly proven by this trial.Evidence: MFS HR 0.886 (95% CI 0.688–1.140); overall survival HR 0.882 (95% CI 0.651–1.194), p=0.42.
“Given the known morbidity of ADT, together with its uncertain long-term benefits in this setting, there has been no consensus on the use of short-course ADT in patients receiving postoperative radiotherapy after previous radical prostatectomy.”
Limitations - supportedReviewers 1, 2, 3Adding 6 months of ADT to postoperative radiotherapy did not improve metastasis-free survival compared with no ADT.The primary outcome analysis shows HR 0.886 (95% CI 0.688–1.140, p=0.35), which is not statistically significant, supporting the claim.Evidence: HR 0.886, 95% CI 0.688–1.140, p=0.35; 10-year metastasis-free survival 79.2% vs 80.4%
“Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT.”
Abstract - supportedReviewers 1, 2, 3These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population.The primary outcome is negative, and the secondary benefits (delayed salvage ADT) are not considered sufficient to change practice, consistent with the claim.Evidence: Primary result negative; Discussion states that reduction in salvage ADT may not justify 6 months of ADT.
“These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population.”
Abstract - supportedReviewers 1, 2, 3Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy.The 10-year metastasis-free survival is around 80% in both groups, and the number of metastases is low (137 out of 1480), supporting the claim.Evidence: 10-year metastasis-free survival 79.2% and 80.4%; 78 patients developed metastases but were alive, 59 had metastases then death.
“Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy.”
Abstract - supportedReviewer 26 months of ADT upfront delayed the time to salvage ADT, improving 10-year freedom from salvage ADT from 73.3% to 82.3%.The secondary outcome time to non-protocol ADT shows a clear benefit (HR 0.543, p<0.0001), and the 10-year rates are reported directly.Evidence: Time to non-protocol ADT HR 0.543 (95% CI 0.422–0.699); 10-year freedom 73.3% vs 82.3%.
“6 months of ADT upfront, at the time of postoperative radiotherapy, improved the 10-year freedom from salvage ADT from 73·3% (95% CI 69·5–76·7) to 82·3% (78·7–85·3).”
Discussion ¶1 - supportedReviewer 3Adding 6 months of ADT did improve the time to salvage ADT.The secondary outcome shows a significant delay in non-protocol ADT use (HR 0.543, p<0.0001).Evidence: HR 0·543 (0·422–0·699); log-rank p<0·0001; 10-year freedom from non-protocol ADT: 73.3% vs 82.3%.
“For time to non-protocol ADT, the HR was 0·543 (0·422–0·699; log-rank p<0·0001)”
Results ¶4 - supportedReviewer 3Short-course ADT is unlikely to improve overall survival in this setting.The lack of improvement in metastasis-free survival, a validated surrogate for overall survival, and the overall survival HR (0.882, p=0.42) support this.Evidence: Overall survival HR 0·882 (0·651–1·194), p=0·42; no improvement in metastasis-free survival.
“given that it had no meaningful impact on metastasis-free survival, short-course ADT is unlikely to improve overall survival in this setting.”
Discussion ¶2
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.
- Ethics/consent reporting incompleteAssessed
- Key resources under-identified (antibodies, cell lines, RRIDs)Assessed
The introduction cites prior randomized trials (GETUG-AFU 16, RTOG 0534) and surveys, and explains the uncertainty regarding short-course ADT in postoperative radiotherapy. The rationale for using metastasis-free survival as the primary outcome is explicitly stated, addressing the limitation of PSA-based outcomes. The study's design directly addresses the need for clinically meaningful endpoints.
“Given the known morbidity of ADT, together with its uncertain long-term benefits in this setting, there has been no consensus on the use of short-course ADT in patients receiving postoperative radiotherapy after previous radical prostatectomy.”
“Given the limitations of PSA-based outcome measures in any trial of ADT, we used metastasis-free survival as the primary outcome measure.”
“Two randomised controlled trials, GETUG-AFU 16 and RTOG 0534, have previously tested the addition of short-course ADT to salvage radiotherapy to the prostate bed.”
“ADT will inevitably delay PSA progression, and that alone should not be sufficient to change practice.”
“Given the limitations of PSA-based outcome measures in any trial of ADT, we used metastasis-free survival as the primary outcome measure.”
“This change followed new evidence from the ICECaP study that metastasis-free survival was a robust early surrogate outcome measure for disease-specific survival.”
“With 200 events from the 1480 participants, this final design had 80% power with two-sided α of 5% to detect an increase in 10-year metastasis-free survival from 80% to 86% (HR=0·67).”
Randomization was done centrally using minimization with a random element, stratified by multiple factors. The trial had 80% power to detect a clinically meaningful difference. Inclusion and exclusion criteria are clearly defined. The intention-to-treat principle is followed. Blinding was not done (open-label), which is stated but not justified. The comparator arm (no ADT) is appropriate. No independent replication cohort is reported, which is expected for a single pivotal trial.
“Recruitment and random allocation of participants was implemented centrally using minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system.”
“With 200 events from the 1480 participants, this final design had 80% power with two-sided α of 5% to detect an increase in 10-year metastasis-free survival from 80% to 86% (HR=0·67).”
“The allocated treatment was open label.”
“Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system.”
“The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67).”
“The allocated treatment was open label.”
“Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system.”
“The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67).”
“Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent.”
Median age is reported with IQR. Health status is reported via Charlson Comorbidity Index. Race and ethnicity data were not collected, which is a minor limitation. Sex is not explicitly stated but is inherent to the disease. Weight is not reported, but this is not a key variable in this trial. The single-sex nature is justified by the disease.
“The median age of participants was 66 years (IQR 61–69)”
“Data on race and ethnicity were not collected.”
“To our knowledge, RADICALS-HD is the first randomised trial of short-course ADT in men having postoperative radiotherapy that has used a long-term, clinically meaningful, primary outcome measure of metastasis-free survival.”
“Data on race and ethnicity were not collected.”
“1480 patients (median age 66 years [IQR 61–69]) were randomly assigned”
“Data on race and ethnicity were not collected.”
The paper states 'Appropriate ethical review was in place for each participating country' without naming the specific ethics committee or providing a protocol number. Informed consent is mentioned. No explicit statement of compliance with the Declaration of Helsinki or ICH-GCP is given. The trial registration numbers are provided, which implies some regulatory oversight.
“Appropriate ethical review was in place for each participating country ().”
“All participants gave written informed consent.”
“Appropriate ethical review was in place for each participating country ().”
“All participants gave written informed consent.”
“Appropriate ethical review was in place for each participating country ().”
“All participants gave written informed consent.”
The ADT drugs (gonadotropin-releasing hormone analogue, bicalutamide, degarelix) are described with dose and route, but no manufacturer or source is given. Stata 17.0 is identified. No other biological resources (antibodies, cell lines) are used. Thus, one of two applicable criteria is adequate, leading to a warn.
“Participants were given ADT using gonadotropin-releasing hormone analogue therapy according to site choice using their indicated route, usually subcutaneously, with once-monthly injections recommended. This was supplemented by 3 weeks of an anti-androgen started 1 week before the first gonadotropin-releasing hormone analogue therapy administration. Outside of Canada, daily oral bicalutamide monotherapy 150 mg or monthly subcutaneous degarelix (with nationally approved dosing) were acceptable alternatives.”
“Participants were given ADT using gonadotropin-releasing hormone analogue therapy according to site choice using their indicated route, usually subcutaneously, with once-monthly injections recommended.”
“All analyses followed the intention-to-treat principle, with analyses according to allocated group, and were conducted in Stata version 17.0.”
“All analyses followed the intention-to-treat principle, with analyses according to allocated group, and were conducted in Stata version 17.0.”
The paper uses log-rank tests, Cox regression, competing risks regression, and chi-square tests. Proportional hazards assumption is tested. Exact p-values are reported (e.g., p=0.35, p<0.0001). Hazard ratios with 95% CIs are given for all primary and secondary outcomes. Data are presented in tables and Kaplan-Meier curves. The numbers in tables are internally consistent.
“metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35).”
“Risk tables present the number of participants who, at each timepoint, remain at risk, have been censored, or have had an event.”
“For time-to-event outcome measures, the statistical significance of differences between groups was evaluated with the log-rank test, stratified by randomisation stratification factors. Effect estimates were obtained from Cox regression models, also stratified by randomisation stratification factors.”
“0·886 (0·688–1·140)”
“For time-to-event outcome measures, the statistical significance of differences between groups was evaluated with the log-rank test, stratified by randomisation stratification factors. Effect estimates were obtained from Cox regression models, also stratified by randomisation stratification factors.”
“HR 0·886 [95% CI 0·688–1·140], p=0·35”
The paper includes a dedicated Data sharing section describing a controlled access process via the MRC CTU with a formal application. This is adequate for a clinical trial. No code repository is mentioned, but no bespoke code is indicated.
“Requests for data can be made at any time and can be initiated by email to mrcctu.datareleaserequest@ucl.ac.uk or via our website.”
“The RADICALS trial data are held at the MRC Clinical Trials Unit at UCL, which encourages optimal use of data by using a controlled access approach to data sharing (https://www.mrcctu.ucl.ac.uk/our-research/other-research-policy/data-sharing/) . Requests for data can be made at any time and can be initiated by email to mrcctu.datareleaserequest@ucl.ac.uk or via our website.”
The methods are comprehensive. The trial is registered with ISRCTN and ClinicalTrials.gov. All pre-specified outcomes are reported, including negative results. Limitations are explicitly discussed. Conclusions are appropriately cautious. Funding sources and conflicts of interest are declared. The paper does not explicitly mention CONSORT, but it is well-structured.
“Grant funding in the UK was provided by the Clinical Trials Advisory Award Committee on behalf of Cancer Research UK (UK/C7829/A6381). Funding in Canada was provided by the Canadian Cancer Society (704970).”
“This study is registered with the ISRCTN registry, ISRCTN40814031, and with ClinicalTrials.gov (https://ClinicalTrials.gov) , NCT00541047 .”
“RADICALS-HD has several limitations.”
“Grant funding in the UK was provided by the Clinical Trials Advisory Award Committee on behalf of Cancer Research UK (UK/C7829/A6381). Funding in Canada was provided by the Canadian Cancer Society (704970).”
“The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047 .”
“In our view, these findings are not sufficient to routinely recommend the use of short-course ADT with postoperative radiotherapy.”
Registered (3 IDs: ClinicalTrials.gov, ISRCTN, PROSPERO). 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 19 references by DOI: 18 verified — 1 DOI unresolved.
- UNRESOLVED10.5281/zenodo.6586525RADICALS trial statistical analysis planCited DOI does not resolve to any Crossref record.
2 data/code links checked; 2 live.
- datahttps://www.mrcctu.ucl.ac.uk/our-research/other-research-policy/data-sharing/LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- datahttp://www.ctu.mrc.ac.uk/our_research/datasharingLIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
3 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 3 minor suggestions below.
3 copyedit issues flagged: mostly consistency, clarity, other.
- MINORconsistencyAuthor affiliations and main text“The affiliation section mixes author names and affiliations without clear line breaks.”→ Reformat the author list with clear affiliation markers.The first paragraph of the paper text contains a long run-on list of authors and affiliations without punctuation, likely a parsing artifact but could be cleaned.
- MINORclarityReporting of p-values“p<0·0001”→ Report exact p-values where possible.Exact p-values are preferred per modern reporting standards.
- MINORotherData sharing statement“The specific data and associated documents to be shared will be dependent on the nature of the individual request and this will be docu”→ Complete the final sentence about data sharing documentation.The text appears truncated at the end.
The published report is methodologically robust and sufficiently transparent for readers to assess the trial's findings; the null primary-outcome result is presented with appropriate caution and the secondary-outcome signal is clearly contextualised. The documentation gaps (unnamed ethics committee, absent regulatory-compliance statement, missing drug manufacturer, unreported race/ethnicity) do not invalidate the trial, but they would warrant a published correction or author clarification, especially verifying the unfound analysis-plan reference and checking whether the data-sharing sentence was truncated in print. An independent re-analysis is not warranted on the evidence reviewed: the machine-verifiable statistics were consistent and no fabrication signals were found.
- 1.HIGHotherVerify that the 'RADICALS trial statistical analysis plan' reference (DOI 10.5281/zenodo.6586525) exists and is cited correctly — it could not be located in Crossref/OpenAlex; if it cannot be verified, remove or correct it.An unlocatable reference is a fabrication signal that an informed reader or post-publication reviewer will check.
- 2.HIGHethicsAdd a named research ethics committee/IRB and the approval/protocol number(s) to the ethics-approval statement in Methods (Study design and participants); if records permit, publish this as a correction, and complete the empty parenthetical placeholder.A vague 'appropriate ethical review was in place' statement leaves the approval unverifiable and does not meet standard reporting expectations.
- 3.HIGHethicsAdd an explicit statement of regulatory compliance (e.g., 'conducted in accordance with the Declaration of Helsinki and ICH-GCP') to the Methods.Regulatory compliance was not reported; naming the framework confirms the trial met international ethical standards.
- 4.HIGHrigorSpecify the manufacturers/sources of the investigational ADT drugs (GnRH analogue, bicalutamide 150 mg, degarelix) in Methods (Procedures), or state that they were site-choice nationally approved products.Investigational-product identification is incomplete without a source, flagged by two of three reviews as a key-resource gap.
- 5.HIGHdata codeCheck the published Data sharing section for a truncated final sentence ('...this will be docu') and, if truncated in print, issue a correction to complete it.An availability statement that reads as cut off undercuts the data-availability claim and invites reader concern.
- 6.MEDIUMreportingAdd an explicit statement of adherence to the CONSORT reporting guideline and indicate where the completed checklist is available.The report follows CONSORT structure but never references the guideline, a minor transparency gap consistent across all reviews.
- 7.MEDIUMrigorAdd an explicit scientific justification for the single-sex (male-only) study population (disease biology of prostate cancer) in the Methods or Discussion.Two reviewers noted the absence of an explicit sex justification even though the reason is self-evident for prostate cancer.
- 8.MEDIUMrigorStrengthen the Discussion of the missing race/ethnicity data and its implications for generalisability, or report the data if available.The paper states race/ethnicity were not collected but does not elaborate the limitation; demographic reporting was judged incomplete.
- 9.MEDIUMreportingAdd a brief rationale for the open-label design (e.g., impracticality of blinding given ADT side-effects) to the Randomisation and masking section.The open-label design is stated but not justified, a minor reporting gap noted by two reviewers.
- 10.MEDIUMstatisticsReplace threshold-only p-values ('p<0·0001') with exact values for secondary outcomes in Table 2 and the Results text, or confirm the journal's convention permits threshold notation.Exact p-values are the modern reporting standard; one reviewer and the copyedit pass both flagged the threshold notation.
- 11.MEDIUMdata codeDeposit the analysis code (e.g., Stata do-files) in a public repository or make it available through the MRC CTU controlled-access route.Sharing code would strengthen reproducibility; no code is currently mentioned even though analyses used a named software package.
- 12.LOWcopyeditReformat the author affiliations block to clearly separate authors from institutions, fixing the run-on list in the opening paragraph.The affiliations currently read as an unpunctuated run-on, a minor clarity issue that will distract a careful reader.
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.
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