Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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.

Name: Kaimen Rigor review — 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.
Item: 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.
Rating: 100
Author: Alpha1

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

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 3 high issues for “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.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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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.

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DOI

10.1136/bmj-2024-083605

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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.

Paper source

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

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★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

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.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
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…”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
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.”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 103AuthenticityData authenticity concerns 04DisclosureNone found 105AvailabilityBroken references and links 06Copyedit6 minor suggestions

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 low

Values 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.

Overstated conclusions

3 findings · worst high

Conclusions 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.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

1 finding · worst low

An 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).

Reporting gaps

None found

Required 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.

Eight Dimensions8 pass

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.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise, citing prior work on aphasia, C7 nerve transfer, and intensive SLT, and provides a logical rationale for the study hypothesis.

Evidence

“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.”

Introduction ¶1Find in source

“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.”

Introduction ¶3Find in source

absence[Introduction]

The paper does not explicitly discuss limitations of prior research.

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale linking clinical observations to the study hypothesis.

Evidence

Introduction ¶1Find in source

“We hypothesised that a combination of C7 neurotomy plus intensive SLT might have a cumulative effect on improving language function.”

Introduction ¶3Find in source

absence[Introduction]

Limitations of prior research are not explicitly discussed.

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.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: multicentre, assessor-blinded, randomised, with a pre-specified sample size calculation, clear inclusion/exclusion criteria, and a defined analysis population.

Evidence

“An independent third party (Trial Data Pharmaceutical Technology, Shanghai, China) carried out randomisation through a centralised interactive web based randomisation system.”

MethodsFind in source

“However, the outcome assessors were blinded.”

MethodsFind in source

“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.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The trial design is rigorous with adequate randomisation, blinding of outcome assessors, a priori sample size calculation, and clear inclusion/exclusion criteria.

Evidence

“An independent third party (Trial Data Pharmaceutical Technology, Shanghai, China) carried out randomisation through a centralised interactive web based randomisation system.”

MethodsFind in source

“However, the outcome assessors were blinded.”

MethodsFind in source

Statistical analysisFind in source

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.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are adequately reported for a human trial: sex, age, and health status are provided in baseline characteristics.

Evidence

paraphrase[Table 1]

“Sex: Men 20 (80.0) 19 (76.0) Women 5 (20.0) 6 (24.0)”

paraphrase[Table 1]

“Type of stroke: Haemorrhagic 13 (52.0) 12 (48.0) Ischaemic 12 (48.0) 13 (52.0)”

PASSReviewer 2· 90% conf

Sex, age, and health status are reported; demographics are adequate for a human trial.

Evidence

paraphrase[Table 1]

“Age at consent (years): Mean (SD) 53.0 (6.3) | 52.1 (7.5)”

“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)”

MethodsFind in source

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.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are adequately reported.

Evidence

“The trial protocol was approved by the institutional review boards of all the trial centres, and all participants provided written informed consent.”

EthicsFind in source

PASSReviewer 2· 90% conf

Ethical approval and informed consent are reported adequately.

Evidence

“The trial protocol was approved by the institutional review boards of all the trial centres, and all participants provided written informed consent.”

EthicsFind in source

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.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (C7 neurotomy) is described, and software tools are identified; no other biological/chemical resources are used.

Evidence

“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.”

MethodsFind in source

“All statistical analyses were performed using R software (version 4.3.2).”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (C7 neurotomy) is described, and software tools are identified; other resource types are not applicable.

Evidence

“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.”

MethodsFind in source

“All statistical analyses were performed using R software (version 4.3.2).”

Statistical analysisFind in source

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.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic errors detected.

Evidence

“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.”

Statistical analysisFind in source

“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”

ResultsFind in source

PASSReviewer 2· 85% conf

Statistical methods are appropriate and well described; p-values are reported as thresholds but effect sizes with CIs are provided.

Evidence

“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.”

Statistical analysisFind in source

“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”

ResultsFind in source

paraphrase[Table 2]

“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.

Sub-criteria

code sharingN/A

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data availability statement is provided with a public repository link; code sharing is not applicable as no custom code is mentioned.

Evidence

“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”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability statement provides a concrete public repository link; code sharing is not applicable.

Evidence

“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”

Data availabilityFind in source

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.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are declared.

Evidence

“Trial registration Chinese Clinical Trial Register ChiCTR2200057180.”

AbstractFind in source

“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.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are declared.

Evidence

“Trial registration Chinese Clinical Trial Register ChiCTR2200057180.”

AbstractFind in source

“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.”

LimitationsFind in source

“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).”

FundingFind in source

Registered (1 ID: Chinese Clinical Trial Registry). No reporting guideline cited.

Broken references and links

1 finding · worst low

References 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.

1 data/code link found; not probed for liveness in this run.

Copyediting

6 minor

Wording, 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.

Kaimen Rigor Action ItemsFinal pass before journal submission

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.
HIGHreporting
Verify 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.
HIGHreporting
Explicitly 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.
HIGHethics
Add 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.
MEDIUMstatistics
Report 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.
MEDIUMreporting
In 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.
MEDIUMreporting
In 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.
MEDIUMreporting
Provide 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 code
Clarify 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.
MEDIUMreporting
In 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.
MEDIUMreporting
Include 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.
LOWcopyedit
In the Abstract, change '40-65 years' to '40–65 years' (en dash) for consistency in number ranges.
Minor typographical consistency issue.
12.
LOWcopyedit
In Table 2 footnote, change 'comprehension, repetition; and naming' to 'comprehension, repetition, and naming'.
Punctuation error; semicolon should be a comma.
13.
LOWcopyedit
In 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.
LOWcopyedit
In 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.
LOWcopyedit
In the Abstract, consider adding 'follow-up' after 'one month' for clarity.
Minor clarity issue.

Full text (49,884 chars)Analyzed: Aug 15, 2026

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Read alongside

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.

Read full text (PMC)

DOI

10.1136/bmj-2024-083605

Share this Kaimen Rigor review

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Record fingerprint

9638e24d4e1f0d43e6e95a7eabee40b796e3d25b161328ad6787ebca9f989970

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

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★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

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.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
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…”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
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.”
Find in source

Findings by category

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.

Overstated conclusions

3 findings · worst high

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.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

1 finding · worst low

Data look implausibly cleanAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise, citing prior work on aphasia, C7 nerve transfer, and intensive SLT, and provides a logical rationale for the study hypothesis.

Evidence

Introduction ¶1Find in source

“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.”

Introduction ¶3Find in source

absence[Introduction]

The paper does not explicitly discuss limitations of prior research.

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale linking clinical observations to the study hypothesis.

Evidence

Introduction ¶1Find in source

“We hypothesised that a combination of C7 neurotomy plus intensive SLT might have a cumulative effect on improving language function.”

Introduction ¶3Find in source

absence[Introduction]

Limitations of prior research are not explicitly discussed.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: multicentre, assessor-blinded, randomised, with a pre-specified sample size calculation, clear inclusion/exclusion criteria, and a defined analysis population.

Evidence

“An independent third party (Trial Data Pharmaceutical Technology, Shanghai, China) carried out randomisation through a centralised interactive web based randomisation system.”

MethodsFind in source

“However, the outcome assessors were blinded.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The trial design is rigorous with adequate randomisation, blinding of outcome assessors, a priori sample size calculation, and clear inclusion/exclusion criteria.

Evidence

“An independent third party (Trial Data Pharmaceutical Technology, Shanghai, China) carried out randomisation through a centralised interactive web based randomisation system.”

MethodsFind in source

“However, the outcome assessors were blinded.”

MethodsFind in source

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are adequately reported for a human trial: sex, age, and health status are provided in baseline characteristics.

Evidence

paraphrase[Table 1]

“Sex: Men 20 (80.0) 19 (76.0) Women 5 (20.0) 6 (24.0)”

paraphrase[Table 1]

“Type of stroke: Haemorrhagic 13 (52.0) 12 (48.0) Ischaemic 12 (48.0) 13 (52.0)”

PASSReviewer 2· 90% conf

Sex, age, and health status are reported; demographics are adequate for a human trial.

Evidence

paraphrase[Table 1]

“Age at consent (years): Mean (SD) 53.0 (6.3) | 52.1 (7.5)”

MethodsFind in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are adequately reported.

Evidence

“The trial protocol was approved by the institutional review boards of all the trial centres, and all participants provided written informed consent.”

EthicsFind in source

PASSReviewer 2· 90% conf

Ethical approval and informed consent are reported adequately.

Evidence

“The trial protocol was approved by the institutional review boards of all the trial centres, and all participants provided written informed consent.”

EthicsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (C7 neurotomy) is described, and software tools are identified; no other biological/chemical resources are used.

Evidence

MethodsFind in source

“All statistical analyses were performed using R software (version 4.3.2).”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (C7 neurotomy) is described, and software tools are identified; other resource types are not applicable.

Evidence

MethodsFind in source

“All statistical analyses were performed using R software (version 4.3.2).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic errors detected.

Evidence

“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.”

Statistical analysisFind in source

“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”

ResultsFind in source

PASSReviewer 2· 85% conf

Statistical methods are appropriate and well described; p-values are reported as thresholds but effect sizes with CIs are provided.

Evidence

“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.”

Statistical analysisFind in source

“group difference 8.51, 95% confidence interval (CI) 5.31 to 11.71, P<0.001”

ResultsFind in source

paraphrase[Table 2]

“P<0.001”

Sub-criteria

code sharingN/A

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data availability statement is provided with a public repository link; code sharing is not applicable as no custom code is mentioned.

Evidence

“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”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability statement provides a concrete public repository link; code sharing is not applicable.

Evidence

“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”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are declared.

Evidence

“Trial registration Chinese Clinical Trial Register ChiCTR2200057180.”

AbstractFind in source

“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.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are declared.

Evidence

“Trial registration Chinese Clinical Trial Register ChiCTR2200057180.”

AbstractFind in source

“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.”

LimitationsFind in source

FundingFind in source

Registered (1 ID: Chinese Clinical Trial Registry). No reporting guideline cited.

Broken references and links

1 finding · worst low

References 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.

1 data/code link found; not probed for liveness in this run.

Copyediting

6 minor

Wording, 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.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
Verify 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.
HIGHreporting
Explicitly 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.
HIGHethics
Add 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.
MEDIUMstatistics
Report 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.
MEDIUMreporting
In 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.
MEDIUMreporting
In 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.
MEDIUMreporting
Provide 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 code
Clarify 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.
MEDIUMreporting
In 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.
MEDIUMreporting
Include 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.
LOWcopyedit
In the Abstract, change '40-65 years' to '40–65 years' (en dash) for consistency in number ranges.
Minor typographical consistency issue.
12.
LOWcopyedit
In Table 2 footnote, change 'comprehension, repetition; and naming' to 'comprehension, repetition, and naming'.
Punctuation error; semicolon should be a comma.
13.
LOWcopyedit
In 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.
LOWcopyedit
In 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.
LOWcopyedit
In the Abstract, consider adding 'follow-up' after 'one month' for clarity.
Minor clarity issue.

Full text (49,884 chars)Analyzed: Aug 15, 2026