Right C7 neurotomy at the intervertebral foramen plus intensive speech and language therapy versus intensive speech and language therapy alone for chronic post-stroke aphasia: multicentre, randomised controlled trial.
Feng J, Hu R, Lyu M, Ma X, Li T, Meng Y, Qi W, Li H, Zhang Y, Ding S, Wang Z, Chen X, Zheng J, Fan Y, Ding L, Wang L, Wei Z, Zhu X, Guo M, Yang K, Chang W, Yang J, Xu M, Fang W, Liu Y, Qiu Y, Yin H, Jia J, Shen Y, Wang Y, Gu Y, Xu W
- DOI
- 10.1136/bmj-2024-083605
- 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/7ae21179-fa2e-4f64-9617-940619457ebc is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- CitationsUnresolved reference−0.25★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 28 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 outcome is the Boston Naming Test (BNT) score, a measure of naming ability, which is a surrogate for language function and clinical benefit. The paper does not provide evidence that the BNT is a validated surrogate for meaningful clinical outcomes in chronic aphasia, nor does it demonstrate target engagement at the tested dose (e.g., PK/PD or dose-exposure relationship) for the surgical intervention. The improvement in BNT is presented as proof of clinical benefit without linking it to a hard clinical outcome or validated surrogate.
“The primary outcome was change in score on the 60 item Boston naming test (BNT, scores 0-60, with higher scores indicating better naming function) from baseline to one week after C7 neurotomy plus intensive SLT for three weeks or intensive SLT for three weeks…”
- 02Treatment effect not shown to be clinically meaningful
The primary effect is a mean increase of 11.16 points on the BNT (out of 60) in the intervention group, which is about 18.6% of the maximum score. The paper does not anchor this change to a minimal clinically important difference (MCID) or other clinical meaningfulness; it only states that 5.5 points was considered clinically important but not the MCID. The effect size is presented as statistically significant but lacks a clear anchor to clinical meaningfulness.
“We considered a between group difference in functional improvement of 5.5 points to be of clinical importance, although 5.5 points did not represent the threshold for minimal clinically important difference.”
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 transparently reported randomised controlled trial. The methodology is rigorous, with adequate randomisation, blinding of outcome assessors, sample size calculation, and statistical analysis. Minor reporting gaps include lack of explicit discussion of prior research limitations, no explicit mention of a reporting guideline, and threshold-only p-values for some outcomes.
Both reviewers classified the study as interventional, and I adopt that classification. The evaluation covered all eight dimensions; sub-criteria not applicable to a human surgical trial (e.g., species/strain, housing, cell line authentication) were excluded. The reviewers diverged slightly on the 'controls' sub-criterion in study design (one marked not applicable, the other reported and adequate) and on exact p_values in statistical analysis (one adequate, one inadequate); these were resolved by weighing the evidence, as detailed in the respective dimensions.
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 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Primary outcome between-group difference at one month: p-value from ANCOVA with 95% CI.
“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”
Taken as given: The CI is a 95% confidence interval for the mean difference.; The estimate is the adjusted mean difference from ANCOVA.; The p-value is two-sided.Method: Recomputed p-value from the reported estimate and 95% CI using the normal approximation for the difference in means.How we recomputed it: pCI(8.51, 5.31, 11.71, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Secondary outcome: change in WAB-AQ total at one month: p-value from ANCOVA with 95% CI.
“difference at one month 7.06 points, 4.41 to 9.72, P<0.001”
Taken as given: The CI is a 95% confidence interval for the mean difference.; The estimate is the adjusted mean difference from ANCOVA.; The p-value is two-sided.Method: Recomputed p-value from the reported estimate and 95% CI using the normal approximation.How we recomputed it: pCI(7.06, 4.41, 9.72, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Primary outcome between-group difference at one month (ANCOVA adjusted mean difference)
“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”
Taken as given: The reported difference is the adjusted mean difference from ANCOVA.; The 95% CI is two-sided.; The p-value is two-sided.Method: Recomputed two-sided p-value from the reported estimate and 95% CI using the normal approximation.How we recomputed it: pCI(8.51, 5.31, 11.71, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Secondary outcome: change in BNT at three days between-group difference
“group difference 5.08, 3.44 to 6.71, P<0.001”
Taken as given: The reported difference is the adjusted mean difference from ANCOVA.; The 95% CI is two-sided.; The p-value is two-sided.Method: Recomputed two-sided p-value from the reported estimate and 95% CI using the normal approximation.How we recomputed it: pCI(5.08, 3.44, 6.71, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Secondary outcome: change in WAB-AQ at one month between-group difference
“difference at one month 7.06 points, 4.41 to 9.72, P<0.001”
Taken as given: The reported difference is the adjusted mean difference from ANCOVA.; The 95% CI is two-sided.; The p-value is two-sided.Method: Recomputed two-sided p-value from the reported estimate and 95% CI using the normal approximation.How we recomputed it: pCI(7.06, 4.41, 9.72, 0)
- lowinternal contradictionThe abstract states 'Mean increase in BNT score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group at one month', but the results section says 'Mean change in BNT score from baseline to one month was 11.16 (SD 7.10) points in the neurotomy plus intensive SLT group versus 2.72 (3.40) points in the control group'. These are consistent, but the abstract omits SDs, which is not a contradiction.
“Mean increase in BNT score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group at one month”
AbstractFind in source
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
7 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, 2C7 neurotomy induces neuroplasticity in the right hemisphere.Functional MRI shows correlations between BNT score and brain activation in right hemisphere regions, but this is correlational and based on a small sample.Evidence: Functional MRI results show BNT score correlated with activation in right supramarginal gyrus and right inferior frontal gyrus at one month.
“The BNT score in the neurotomy plus intensive SLT group correlated with brain activation in right supramarginal gyrus and right inferior frontal gyrus at one month”
ResultsFind in source - supportedReviewers 1, 2C7 neurotomy plus intensive SLT improves language function compared with intensive SLT alone in chronic post-stroke aphasia.The primary outcome (BNT change) shows a statistically significant and clinically meaningful difference favouring the intervention group, supported by sensitivity analyses.Evidence: Primary outcome: mean BNT change 11.16 vs 2.72, difference 8.51 (95% CI 5.31-11.71, P<0.001).
“Mean increase in BNT score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group at one month (difference 8.51 points, 95% confidence interval (CI) 5.31 to 11.71, P<0.001).”
AbstractFind in source - supportedReviewer 1The improvement in language function remained stable at six months.The six-month BNT difference (8.26 points) is similar to the one-month difference and statistically significant.Evidence: Six-month BNT difference 8.26 (95% CI 4.16-12.35, P<0.001).
“The between group difference in BNT score remained stable at six months (difference 8.26 points, 4.16 to 12.35, P<0.001).”
AbstractFind in source - supportedReviewers 1, 2C7 neurotomy plus intensive SLT improves aphasia quotient and patient-reported outcomes.Secondary outcomes show significant improvements in WAB-AQ and Barthel index, though some secondary outcomes were not significant at all time points.Evidence: WAB-AQ difference at one month 7.06 (95% CI 4.41-9.72, P<0.001); Barthel index at one month 4.12 (95% CI 0.23-8.00, P=0.04).
“the aphasia quotient improved significantly in the neurotomy plus SLT group versus control group (difference at one month 7.06 points, 4.41 to 9.72, P<0.001), as did patient reported activities of daily living and post-stroke depression.”
AbstractFind in source - supportedReviewer 1No treatment-related severe adverse events were reported.The safety data show no severe adverse events, though neuropathic pain was common but transient.Evidence: Safety outcomes section reports no severe treatment-related adverse events; 15 patients used analgesics for a median of 32 days.
“No severe treatment related adverse events were reported.”
ResultsFind in source - supportedReviewer 2The improvement in language function is maintained at six months.The six-month BNT difference (8.26, 95% CI 4.16 to 12.35, P<0.001) supports sustained benefit.Evidence: Change in BNT at six months: difference 8.26 (4.16 to 12.35, P<0.001).
Treatment effects remained significantly stable at six months (group difference 8.26, 4.16 to 12.35, P<0.001).
Resultsreviewer’s wording - supportedReviewer 2C7 neurotomy is safe with no severe adverse events.No severe treatment-related adverse events were reported; adverse events were transient and resolved by six months.Evidence: Safety outcomes: no severe adverse events; neuropathic pain resolved within two months; sensorimotor deficits resolved by six months.
“No severe treatment related adverse events were reported.”
ResultsFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary outcome is the Boston Naming Test (BNT) score, a measure of naming ability, which is a surrogate for language function and clinical benefit. The paper does not provide evidence that the BNT is a validated surrogate for meaningful clinical outcomes in chronic aphasia, nor does it demonstrate target engagement at the tested dose (e.g., PK/PD or dose-exposure relationship) for the surgical intervention. The improvement in BNT is presented as proof of clinical benefit without linking it to a hard clinical outcome or validated surrogate.
“The primary outcome was change in score on the 60 item Boston naming test (BNT, scores 0-60, with higher scores indicating better naming function) from baseline to one week after C7 neurotomy plus intensive SLT for three weeks or intensive SLT for three weeks after deferral for one week (control group).”
- INADEQUATEEffect sizeThe primary effect is a mean increase of 11.16 points on the BNT (out of 60) in the intervention group, which is about 18.6% of the maximum score. The paper does not anchor this change to a minimal clinically important difference (MCID) or other clinical meaningfulness; it only states that 5.5 points was considered clinically important but not the MCID. The effect size is presented as statistically significant but lacks a clear anchor to clinical meaningfulness.
“We considered a between group difference in functional improvement of 5.5 points to be of clinical importance, although 5.5 points did not represent the threshold for minimal clinically important difference.”
Data authenticity concerns
1 finding · worst lowAn 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.
- Data look implausibly cleanAssessed
2 integrity concerns flagged (0 high).
- lowdata too cleanThe primary outcome shows a large and highly significant improvement in the surgical group, but the control group shows minimal change, which might be expected. However, the consistency of improvement across all patients (as implied by the waterfall plot) could be scrutinized.
“Mean change in BNT score from baseline to one month was 11.16 (SD 7.10) points in the neurotomy plus intensive SLT group versus 2.72 (3.40) points in the control group”
ResultsFind in source
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction cites epidemiological data on aphasia prevalence and economic burden, and describes the observation that patients with left-sided stroke and spastic arm paralysis often report improved language function after C7 nerve transfer surgery. This leads to the hypothesis that C7 neurotomy plus intensive SLT might have a cumulative effect. The paper acknowledges the challenge of treating chronic aphasia and the limitations of existing treatments, but does not explicitly discuss limitations of prior research in detail.
“More than one third of people are estimated to experience aphasia during the initial acute stage of hemispheric stroke, and more than 60% continue to be affected for more than a year, referred to as chronic post-stroke aphasia.”
“Patients with left sided stroke and spastic arm paralysis combined with aphasia often report improved language function after C7 nerve transfer surgery, especially in naming objects.”
“More than one third of people are estimated to experience aphasia during the initial acute stage of hemispheric stroke, and more than 60% continue to be affected for more than a year, referred to as chronic post-stroke aphasia.”
“We hypothesised that a combination of C7 neurotomy plus intensive SLT might have a cumulative effect on improving language function.”
Randomisation was performed via a centralised interactive web-based system, stratified by centre, with the statistician generating the sequence not involved in enrolment. Outcome assessors were blinded, and patients wore cervical collars to conceal surgical scars. A sample size calculation was provided (50 participants, 80% power, alpha 0.05). Inclusion/exclusion criteria were detailed. The analysis population (intention-to-treat) and per-protocol sensitivity analysis were defined. Blinding of participants and clinicians was not possible due to the surgical nature, but this is acknowledged.
“An independent third party (Trial Data Pharmaceutical Technology, Shanghai, China) carried out randomisation through a centralised interactive web based randomisation system.”
“However, the outcome assessors were blinded.”
“we estimated that a sample size of 50 participants (25 in each group), under the assumption of a 20% dropout rate, would provide 80% power to detect a mean difference of 5.5 (standard deviation 6.2) points between groups on the BNT score with a two sided α level of 0.05.”
“An independent third party (Trial Data Pharmaceutical Technology, Shanghai, China) carried out randomisation through a centralised interactive web based randomisation system.”
“However, the outcome assessors were blinded.”
“we estimated that a sample size of 50 participants (25 in each group), under the assumption of a 20% dropout rate, would provide 80% power to detect a mean difference of 5.5 (standard deviation 6.2) points between groups on the BNT score with a two sided α level of 0.05.”
The paper reports sex (men/women), age (mean, SD, median, IQR), and health status (type of stroke, aphasia type, spastic arm paralysis) in Table 1. Since both sexes are enrolled, a justification for single-sex is not applicable. Demographics are reported in detail. Species/strain and housing conditions are not applicable for a human trial.
“Patients were eligible for inclusion if they had aphasia for more than 12 months after a single onset of infarction or haemorrhage of the left hemisphere confirmed by magnetic resonance imaging (MRI)”
The paper states that the trial protocol was approved by the institutional review boards of all trial centres, and all participants provided written informed consent. This satisfies both the ethics approval and informed consent criteria. Regulatory compliance is implied but not explicitly named (e.g., Declaration of Helsinki), but the approval statement is adequate.
“The trial protocol was approved by the institutional review boards of all the trial centres, and all participants provided written informed consent.”
“The trial protocol was approved by the institutional review boards of all the trial centres, and all participants provided written informed consent.”
The surgical procedure is described in detail, and the SLT protocol is specified. Statistical software (R version 4.3.2) and fMRI software (FSL version 6.00) are identified. No antibodies, cell lines, or reagents are used, so those criteria are not applicable. The trial is scored because the surgical intervention is the investigational product.
“Briefly, an incision was made at the medial side of the sternocleidomastoid muscle on the right side and the C7 nerve root exposed as proximally as possible and then sectioned at the intervertebral foramen.”
“All statistical analyses were performed using R software (version 4.3.2).”
“an incision was made at the medial side of the sternocleidomastoid muscle on the right side and the C7 nerve root exposed as proximally as possible and then sectioned at the intervertebral foramen.”
“All statistical analyses were performed using R software (version 4.3.2).”
The primary analysis used ANCOVA adjusting for baseline and centre, with sensitivity analyses using mixed models and per-protocol. Tests are named (ANCOVA, Cochran-Mantel-Haenszel, Fisher's exact). Exact p-values are reported (e.g., P<0.001). Effect sizes with 95% CIs are provided. Software is identified. Data presentation includes individual data points (waterfall plot) and per-group n. Mathematical plausibility checks: baseline means and SDs are plausible; no inconsistencies found.
“Analysis of covariance was used to compare changes in continuous outcomes between the two groups from baseline to one month, adjusting for baseline measures and study centres as covariates.”
“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”
“Analysis of covariance was used to compare changes in continuous outcomes between the two groups from baseline to one month, adjusting for baseline measures and study centres as covariates.”
“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”
The data availability statement provides a concrete URL to a public repository (ncmi.cn) with an identifier. This is reported_and_adequate. No custom code is mentioned, so code_sharing is not applicable. Repository deposit and accession numbers are covered by the URL.
“The datasets are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.14.A00AV.202601.55.V1.0”
“The datasets are openly and publicly available and can be found at https://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.14.A00AV.202601.55.V1.0”
Trial registration number is provided (ChiCTR2200057180). Methods are detailed enough for replication. Limitations are discussed (e.g., only Chinese speakers, relatively young participants). Conclusions are proportional to the evidence. Funding sources and competing interests are declared. No reporting guideline (e.g., CONSORT) is explicitly mentioned, but the paper follows standard reporting.
“Trial registration Chinese Clinical Trial Register ChiCTR2200057180.”
“The main limitation of this study was the inclusion of only native Chinese speakers, who were all recruited from the east coast of mainland China.”
“Trial registration Chinese Clinical Trial Register ChiCTR2200057180.”
“The main limitation of this study was the inclusion of only native Chinese speakers, who were all recruited from the east coast of mainland China.”
“This study was funded by the National key R&D programme of China (2022YFC3602700, 2022YFC3602701), National Natural Science Foundation of China (82021002), Shanghai Municipal Clinical Medical Centre Project (2022ZZ01007), and Shanghai Municipal Health Commission (GWVI-11.1-27).”
Registered (1 ID: Chinese Clinical Trial Registry). 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 43 references by DOI: 41 verified — 1 DOI unresolved, 1 lookup failed.
- UNRESOLVED10.1093/ons/opaa325Surgical Technique of Xu’s CC7 Procedure “Contralateral C7 to C7 Cross Nerve Transfer Through a Trans Longus Colli, Prespinal Route for Treating Spastic Arm”Cited DOI does not resolve to any Crossref record.
- NOT CHECKED10.3389/fneur.2022.866261Culture Effects on the Chinese Version Boston Naming Test Performance and the Normative Data in the Native Chinese-Speaking Elders in Mainland China[crossref] rate_limited 429 https://api.crossref.org/works/10.3389%2Ffneur.2022.866261?mailto=editorial%40alpha1science.com: HTTP 429
1 data/code link found; not probed for liveness in this run.
- datahttps://www.ncmi.cn//phda/dataDetails.do?id=CSTR:17970.14.A00AV.202601.55.V1.0UNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
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 typo, consistency, grammar.
- MINORtypoAbstract, Results“Mean increase in BNT score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group at one month”→ Consider adding 'follow-up' after 'one month' for clarity.Minor clarity issue.
- MINORconsistencyTable 2, footnote“Total scores are 20 points for spontaneous speech and 10 points each for comprehension, repetition; and naming.”→ Change semicolon to comma: 'comprehension, repetition, and naming.'Punctuation inconsistency.
- MINORgrammarDiscussion, paragraph 1“The increase in language function remained stable at six months’ follow-up.”→ Consider rephrasing to 'The improvement in language function remained stable at the six-month follow-up.'Minor grammatical improvement.
- MINORtypoAbstract, Participants“50 adults aged 40-65 years”→ Use en dash for age range: 40–65 yearsConsistency in number ranges.
- MINORconsistencyTable 2 footnote“Total scores are 20 points for spontaneous speech and 10 points each for comprehension, repetition; and naming.”→ Change semicolon to comma: 'comprehension, repetition, and naming.'Punctuation error.
- MINORclarityMethods, Outcomes“The primary outcome was change in total score on the 60 item Boston naming test (BNT) of a validated Chinese version from baseline to one week after C7 neurotomy plus three weeks of intensive SLT in the intervention group or from three weeks of intensive SLT after deferral for one week in the control group.”→ Rephrase for clarity: 'The primary outcome was the change in total score on the 60-item Boston Naming Test (BNT) from baseline to one week after C7 neurotomy plus three weeks of intensive SLT in the intervention group, or from baseline to after three weeks of intensive SLT following a one-week deferral in the control group.'Long sentence with ambiguous timing.
The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps (e.g., no explicit CONSORT statement, threshold-only p-values) and the single unresolved reference, but none of these undermine the core findings. No erratum or re-analysis is warranted based on the integrity checks.
- 1.HIGHreportingVerify or correct the reference 'Surgical Technique of Xu’s CC7 Procedure “Contralateral C7 to C7 Cross Nerve Transfer Through a Trans Longus Colli, Prespinal Route for Treating Spastic Arm”' (DOI 10.1093/ons/opaa325) which was not found in any registry; it may be fabricated or have an incorrect DOI.An unresolved reference is a potential fabrication signal that must be resolved before publication.
- 2.HIGHreportingExplicitly state adherence to the CONSORT reporting guideline in the Methods or Acknowledgments.Both reviewers noted the absence of an explicit reporting guideline statement, which is expected for a randomised trial.
- 3.HIGHethicsAdd a statement in the Ethics section confirming adherence to the Declaration of Helsinki or other relevant regulatory framework.Regulatory compliance is implied but not explicitly stated; this is a minor but easily fixed reporting gap.
- 4.MEDIUMstatisticsReport exact p-values (e.g., P=0.001) instead of thresholds like P<0.001 in Table 2 and text where possible.Exact p-values improve statistical transparency and allow readers to assess evidence strength.
- 5.MEDIUMreportingIn the Introduction, explicitly discuss limitations of prior research on C7 nerve transfer and SLT.Both reviewers noted this gap; addressing it strengthens the scientific premise.
- 6.MEDIUMreportingIn the Discussion, discuss the potential impact of lack of blinding of participants and therapists on outcomes.This is a known limitation of surgical trials and should be acknowledged for balanced interpretation.
- 7.MEDIUMreportingProvide the minimal clinically important difference (MCID) for the BNT to contextualize the clinical significance of the observed difference.This helps readers judge whether the statistically significant difference is clinically meaningful.
- 8.MEDIUMdata codeClarify whether any custom code was used for statistical analysis or fMRI processing; if so, provide a repository link.Reproducibility is enhanced when analysis code is shared; the paper currently does not mention any code.
- 9.MEDIUMreportingIn the Methods, provide a more detailed description of the randomisation sequence generation (e.g., random number generator used).This detail is part of CONSORT and improves transparency of the randomisation process.
- 10.MEDIUMreportingInclude a statement on whether the trial was conducted in accordance with ICH-GCP guidelines.This is a standard expectation for clinical trials and would strengthen the ethics reporting.
- 11.LOWcopyeditIn the Abstract, change '40-65 years' to '40–65 years' (en dash) for consistency in number ranges.Minor typographical consistency issue.
- 12.LOWcopyeditIn Table 2 footnote, change 'comprehension, repetition; and naming' to 'comprehension, repetition, and naming'.Punctuation error; semicolon should be a comma.
- 13.LOWcopyeditIn the Methods, Outcomes, rephrase the primary outcome description for clarity: 'The primary outcome was the change in total score on the 60-item Boston Naming Test (BNT) from baseline to one week after C7 neurotomy plus three weeks of intensive SLT in the intervention group, or from baseline to after three weeks of intensive SLT following a one-week deferral in the control group.'The original sentence is long and ambiguous about timing.
- 14.LOWcopyeditIn the Discussion, rephrase 'The increase in language function remained stable at six months’ follow-up' to 'The improvement in language function remained stable at the six-month follow-up.'Minor grammatical improvement.
- 15.LOWcopyeditIn the Abstract, consider adding 'follow-up' after 'one month' for clarity.Minor clarity issue.
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.