Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.

Name: Kaimen Rigor review — Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.
Item: Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.
Rating: 59
Author: Alpha1

Wang Y, Xia D, Xu W, Rexiati M, Zhao W, Huang Q, Shi T, Wang B, Wang S, Tai S, Qiao B, Zhang Y, Ye S, Zhang X, Mao J, Zhu Y, Wang H, Ma S, Yang C, Fu W, Song T, Ai Q, Song Y, Xu L, Yang G, Gao Y, Niu S, Guo J, Liu G, Xiang X, Liang C, Ma X, Li H, Zhang X, TeleS Research Group

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Kaimen Rigor review — 1★ (Critical), 0 critical, 9 high issues for “Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.

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DOI

10.1136/bmj-2024-083588

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.

Paper source

Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×6−3★
ClaimsOverstated claim−0.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Biggest issues

01Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The NASA-TLX surgeon workload adjusted mean difference is −6.26 with 95% CI (−31.52 to −6.41); the point estimate is 0.15 units below the upper CI bound and 25 units above the lower bound, which is not credible for a standard 95% CI and suggests an error in either the estimate or the interval.
“The task load scores of surgeons in the telesurgery and local surgery groups were 29.0 and 48.0, respectively (adjusted mean difference −6.26, 95% CI −31.52 to −6.41; P=0.004; adjusted Cohen’s d=−0.93).”
Table 2Find in source
02Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The QoR-15 6-week adjusted mean difference has 95% CI (0.94 to 31.82), which excludes zero, yet the reported P is 0.06; a 95% CI excluding zero implies a two-sided p<0.05.
“6 weeks | 147.0 (140.0-150.0) | 149.0 (144.0-150.0) | 8.18 (0.94 to 31.82) | 0.53 | 0.06”
Table 2Find in source
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.
“Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.”
AbstractFind in source
04Methods and results do not match
mediumAuthenticityreviewer-assessedFull detail
The complications row lists 'odds ratio 0.031 (−0.03 to 0.09)', but an odds ratio cannot have a negative lower bound; the interval is that of a risk difference, and the footnote attributes the calculation to Fisher's exact test, which would yield p≈1.0 for 1/31 vs 0/31, not the reported P=0.61.
“No (%) complications and adverse events | 1/31 (3) | 0 | 0.031 (−0.03 to 0.09) | 0.03 | 0.61”
Table 2Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 203AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

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 trial is well designed and generally transparently reported: a registered, powered, single-blind multicentre RCT with pre-specified Bayesian analysis, ITT with multiple imputation, named ethics approvals, and open data with a DOI. Its main weaknesses are the multiple demonstrable internal errors in the Table 2 secondary-statistics rows, together with two reporting gaps (missing regulatory-compliance and CONSORT statements) and analysis code confined to supplementary materials.

Two independent reviewer runs (same model) agreed on all eight dimensions; the synthesis downgraded statistical analysis from pass to fail because the copyedit and integrity-verification components documented concrete internal contradictions that satisfy the 'one or more demonstrable errors' fail condition. Machine-statistics verification covered only one recomputable test (consistent); Bayesian posterior probabilities and Fisher's exact p-values in Table 2 are not machine-verifiable, so most reported statistics remain unverified. The citation check found none of 34 references retracted or missing from registries.

Numerical inconsistencies

1 finding · worst medium

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 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

2 findings · worst medium

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.

Conclusions overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

2 findings · worst medium

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.

Methods and results do not matchAssessed
Implausibly large reported effectAssessed

6 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst medium

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.

Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 2 warn

Prior work on telesurgery is cited (e.g., 2001 trans-Atlantic cholecystectomy, urological exploratory trials), and its limitations are acknowledged ('focused on feasibility in narrow indications, and no clinical evidence has been established'). The rationale logically links the premise to the non-inferiority hypothesis. The study is positioned as the first RCT in the field.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear scientific rationale for testing telesurgery reliability, cites prior feasibility work, and explicitly identifies the gap this RCT addresses.

Evidence

paraphrase[Introduction]

“previous studies, including our exploratory trial, focused on feasibility in narrow indications, and no clinical evidence has been established to support further research or the wider application of telesurgery. Therefore, we designed this randomised controlled trial...”

“Despite these prospects, the clinical validity of telesurgery remains unproved.”

IntroductionFind in source

PASSReviewer 2· 90% conf

The paper clearly establishes the scientific premise, citing prior telesurgery work (including the 2001 trans-Atlantic cholecystectomy and the authors' own exploratory trial) and identifies the gap of lacking rigorous clinical evidence.

Evidence

“Early milestone, such as the 2001 trans-Atlantic cholecystectomy, prioritised technical novelty over clinical rigour.”

Introduction ¶2Find in source

“However, previous studies, including our exploratory trial, focused on feasibility in narrow indications, and no clinical evidence has been established to support further research or the wider application of telesurgery.”

Introduction ¶3Find in source

“As this study is the first randomised controlled trial of telesurgery, no established reports were available for reference for determining the non-inferiority margin.”

MethodsFind in source

All applicable design elements for a human RCT are reported adequately: randomization method and unit, blinding (participants, follow-up specialists, statisticians; medical team unblinded with justification), power analysis (α=0.025, power=0.8, n=34/group), inclusion/exclusion criteria, and missing-data handling via multiple imputation. The comparator arm is the local-surgery group, and independent replication is not applicable for a single pivotal trial.

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· 90% conf

Core trial design elements are adequately reported: central stratified randomisation with random block sizes, blinding of participants/assessors with a stated rationale for unmasked surgeons, a priori power calculation, explicit inclusion/exclusion criteria, and ITT/per-protocol analysis with imputation.

Evidence

“The participants were randomly assigned in a 1:1 ratio to undergo either telesurgery or standard local robotic surgery, using stratified randomisation with random block sizes of four.”

Randomisation and maskingFind in source

“Assuming a 10% attrition rate, we determined that a sample size of 34 participants per group was needed.”

Sample size calculationFind in source

“Participants, follow-up specialists (independent research nurses or doctors), and independent statisticians were masked to the form of surgery performed (telesurgery or local surgery).”

Randomisation and maskingFind in source

PASSReviewer 2· 95% conf

The study design is rigorous: stratified randomisation with random block sizes, central web-based randomisation, single-blinding with a rationale for not masking the medical team, a priori power calculation, detailed inclusion/exclusion criteria, and ITT with multiple imputation for missing data.

Evidence

“The participants were randomly assigned in a 1:1 ratio to undergo either telesurgery or standard local robotic surgery, using stratified randomisation with random block sizes of four.”

MethodsFind in source

“As masking of the medical team was not feasible, the determination of surgical success was conducted by the surgical team according to pre-specified criteria to minimise subjectivity.”

MethodsFind in source

paraphrase[Methods, Sample size calculation]

“The unilateral α value was set at 0.025, and the power (1−β) was set at 0.8. ... Assuming a 10% attrition rate, we determined that a sample size of 34 participants per group was needed.”

Table 1 reports sex (e.g., male sex 28/36 vs 26/36), age (median and IQR), height, weight, and BMI, plus tumour characteristics and patient location. Both sexes were enrolled, so a single-sex justification is not applicable. Health status is captured via inclusion criteria and tumour characteristics; comorbidities are addressed in exclusion criteria. Race/ethnicity is omitted, a minor inadequacy for the demographics criterion in the Chinese context.

Sub-criteria

demographicsINADEQUATE

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· 75% conf

Sex, age, weight, BMI, and clinical characteristics are reported in the baseline table; race/ethnicity is not reported, but other demographics and health variables are adequate for a clinical trial.

Evidence

“Male sex, total | 28 (78) | 26 (72)”

Table 1Find in source

“Median (IQR) age, years | 61.0 (57.5-68.0) | 65.0 (56.5-70.0)”

Table 1Find in source

absence[Table 1]

Race/ethnicity is not reported in baseline characteristics.

PASSReviewer 2· 75% conf

Sex and age/weight/BMI are well reported, and demographics are largely covered, though race/ethnicity and a full comorbidity list are not explicitly provided (likely in supplementary).

Evidence

“Male sex, total | 28 (78) | 26 (72) | 24 (75) | 22 (71) |”

Table 1Find in source

“Median (IQR) age, years | 61.0 (57.5-68.0) | 65.0 (56.5-70.0) | 61.0 (57.5-68.0) | 62.0 (53.0-70.5) |”

Table 1Find in source

paraphrase[Table 1]

“Demographics listed include sex, age, height, weight, BMI, tumour characteristics, and patient location, but no race/ethnicity or comorbidity detail is given in the main table.”

The paper states approval by the ethical review committee of Chinese PLA General Hospital (ID:2023-021) and the other four sites, and that participants signed both surgical and research consent. However, there is no sentence naming a regulatory framework such as the Declaration of Helsinki or ICH-GCP. The absence of this sub-criterion triggers a warning per the scoring rule, although the core ethics reporting is adequate.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Named ethics approval and informed consent are reported, but no explicit regulatory-compliance statement (e.g., Declaration of Helsinki or ICH-GCP) is provided.

Evidence

“This study was approved by the ethical review committee of Chinese PLA General Hospital (ID:2023-021) and the other four clinical trial sites.”

EthicsFind in source

“Participants signed a surgical informed consent and a separate research consent before enrolment.”

EthicsFind in source

absence[Ethics statements]

No regulatory compliance framework is stated.

WARNReviewer 2· 80% conf

Ethics approval and informed consent are adequately reported, but the paper does not explicitly state compliance with a recognised regulatory framework (e.g., Declaration of Helsinki).

Evidence

“This study was approved by the ethical review committee of Chinese PLA General Hospital (ID:2023-021) and the other four clinical trial sites.”

EthicsFind in source

“Participants signed a surgical informed consent and a separate research consent before enrolment.”

EthicsFind in source

absence[Ethics statements]

No explicit regulatory compliance statement (e.g., Declaration of Helsinki) is found.

The telesurgery system is identified by model and manufacturer: 'four arm, multi-port Surgical Robotic System (MP1000, Edge Medical Co, Shenzhen, China)'. Statistical software is named (SAS 9.4, RStudio, GraphPad Prism 8.0). Antibodies, cell lines, mycoplasma testing, and organisms are not applicable to this device-trial design. The local-surgery comparator device is not explicitly named, but the back-up console described implies the same system used locally; this is a minor gap but does not warrant a downgrade.

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 device (MP1000 surgical robotic system) and statistical/visualization software are identified with manufacturer/version; bench-resource criteria are not applicable.

Evidence

“We used a four arm, multi-port Surgical Robotic System (MP1000, Edge Medical Co, Shenzhen, China) as the robotic subsystem.”

Telesurgery system structureFind in source

“We used SAS version 9.4 or RStudio for analyses.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational robotic system is identified (MP1000, Edge Medical Co) and analysis software is named with versions; no wet-lab reagents are used, so those criteria are not applicable.

Evidence

“We used a four arm, multi-port Surgical Robotic System (MP1000, Edge Medical Co, Shenzhen, China) as the robotic subsystem.”

MethodsFind in source

“We used SAS version 9.4 or RStudio for analyses.”

Statistical analysisFind in source

paraphrase[Methods]

“The study involves only surgical procedures and no cell lines, antibodies, or mycoplasma testing.”

All applicable sub-criteria are adequate: tests are named (Bayesian mixed-effects logistic regression, mixed-effects linear regression, Fisher's exact test); assumptions are handled by design (Bayesian and mixed models); exact p-values are reported; effect sizes with 95% CIs are given; software and versions are identified; data presentation includes per-group n, CONSORT flow, and appropriate measures of dispersion. Mathematical plausibility checks (e.g., percentages in Table 1) are consistent.

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· 75% conf

Statistical methods are well specified (Bayesian primary analysis, mixed models, Fisher's exact test, multiple imputation), exact p-values and effect sizes with CIs are reported, and software is identified; internal inconsistencies in some secondary-outcome rows are noted separately as integrity concerns.

Evidence

“For the primary outcome, we derived the differences in the probability of success between the groups along with their 95% credible interval from the posterior distributions of the bayesian mixed effect logistic regression with penalised priors accounting for clustering by surgeon, taking the intercept of surgeon as a random effect.”

Statistical analysisFind in source

“All tests were two tailed with significance level α=0.05.”

Statistical analysisFind in source

“We used SAS version 9.4 or RStudio for analyses.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with CIs are reported, exact p-values are given, software is identified, and data presentation follows the clinical-trial idiom; no arithmetic inconsistencies were found.

Evidence

“We used Fisher’s exact test to analysis the risk difference of the Clavin-Dindo complications without stratification.”

Statistical analysisFind in source

paraphrase[Table 2]

“P=0.87; P=0.41; P=0.82; P=0.67; P=0.48; P=0.10; P=0.65; P=0.06; P=0.24; P=0.77; P=0.41; P=0.35; P=0.12; P=0.004; P=0.83; P=0.70; P=0.07; P=0.61”

paraphrase[Table 2]

“Adjusted mean difference 13.67 (95% CI −25.22 to 29.61; P=0.87; adjusted Cohen’s d=0.05)”

The data availability statement is explicit and names a public repository with a DOI (Dryad: https://doi.org/10.5061/dryad.t4b8gtjg8). The code is stated to be in the supplementary materials, which lacks version control and a persistent identifier, so code_sharing is reported_but_inadequate. Sequencing accession numbers are not applicable; managed data access is not needed because the data are open.

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A concrete data-availability statement with a Dryad DOI is provided, but the analysis code is only in supplementary materials rather than a version-controlled public repository, so the code-sharing criterion is inadequate.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at Dryad: https://doi.org/10.5061/dryad.t4b8gtjg8 .”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Data are openly deposited in Dryad with a DOI, and a data availability statement names the repository, but the analysis code is only available in supplementary materials rather than a version-controlled public repository with a persistent identifier.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at Dryad: https://doi.org/10.5061/dryad.t4b8gtjg8 .”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

Trial registration is given (ChiCTR2300077721). Methods are sufficiently detailed for replication. All secondary outcomes are reported, including null results. Limitations are discussed in a dedicated section. Conclusions are proportional. Funding and competing interests are declared. The only missing element is an explicit reporting-guideline statement; however, the paper includes a CONSORT-style flow diagram (Fig 3), so practical adherence is present. Since 6 of 7 applicable criteria are adequate, the dimension passes.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Reporting is generally transparent: trial registration, funding/COI, limitations, and proportional conclusions are present; the only gap is no explicit CONSORT checklist statement.

Evidence

“Trial registration ChiCTR.org ChiCTR2300077721.”

AbstractFind in source

paraphrase[Discussion]

“Strengths and limitations of study ... Secondly, no articles were available for reference in determining the non-inferiority margin. ... Thirdly, although the sample size was estimated on the basis of the predefined non-inferiority margin, we acknowledge that the relatively small cohort in this trial may have limited the ability to detect statistically significant differences in certain outcomes.”

absence[Methods]

No explicit CONSORT statement is present.

PASSReviewer 2· 85% conf

The manuscript is transparent: trial registered, methods detailed, all outcomes reported, limitations discussed, conclusions proportional, funding and COI declared, but no explicit reporting-guideline checklist (e.g., CONSORT) is cited.

Evidence

“Trial registration ChiCTR.org ChiCTR2300077721.”

AbstractFind in source

“Firstly, clinical adoption of telesurgery remains limited, and a notable proportion of trial participants were recruited from non-local regions.”

LimitationsFind in source

paraphrase[Funding and Competing interests]

“Funding: This study was supported by grants from National Natural Science Foundation of China (M-0735)... Competing interests: All authors have completed the ICMJE uniform disclosure form...”

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

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 34 references by DOI: 33 verified — 1 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

13 copyedit issues flagged (4 major): mostly consistency, typo, punctuation.

Kaimen Rigor Action ItemsFinal pass before journal submission

In this post-publication audit, the trial is methodologically robust at the design level, but an informed reader should weigh the Table 2 secondary statistics very cautiously: several rows contain demonstrable internal errors (CI/P contradiction, CI not containing the estimate, a mislabelled effect measure, a denominator mismatch) that warrant a published correction and independent re-analysis before those results are relied upon. The primary non-inferiority finding is not implicated by the flagged rows; the unflagged secondary rows should still be treated as unverified until a corrected table is issued.

1.
HIGHstatistics
Recompute and correct the QoR-15 6-week row in Table 2 (and the corresponding Results text): the reported 95% CI (0.94–31.82) excludes zero, which cannot coexist with P=0.06; publish a correction with a mutually consistent CI and P.
A 95% CI excluding zero implies two-sided P<0.05, so the reported pair is mathematically impossible and misleads readers about a secondary endpoint.
2.
HIGHstatistics
Correct the NASA-TLX surgeon workload row in Table 2: the point estimate (−6.26) lies outside its own 95% CI (−31.52 to −6.41); re-verify the estimate and interval and correct both in a correction.
A CI that does not contain its point estimate is impossible for a standard confidence interval and signals an output or transcription error.
3.
HIGHstatistics
Re-label and re-compute the complications effect measure in Table 2: an 'odds ratio' with a negative lower bound (−0.03 to 0.09) is impossible; if it is a risk difference, label it as such and recompute the P value, since a Fisher's exact test on the stated counts would not yield P=0.61.
The negative lower bound and the method/result mismatch make the reported effect measure invalid as printed.
4.
HIGHstatistics
Reconcile the positive surgical margin denominator in Table 2 (5/32) with the per-protocol local group size (n=31) and the Discussion's 16.1% (5/31), and state the correct fraction in a correction.
An inconsistent denominator in a reported event count undermines confidence in the oncological/complication outcomes.
5.
HIGHstatistics
Clarify the local-group failure count: the text says only one failure was observed in the local surgery group, but the ITT table reports 34/36 success (two failures); state explicitly whether one failure was imputed for a missing outcome and align the wording.
The text and table disagree about a primary-outcome event count, which is essential to interpreting the non-inferiority result.
6.
HIGHreporting
Temper the Abstract's claim that secondary outcomes 'did not differ substantially': surgeon workload differed significantly (NASA-TLX P=0.004), so revise the sentence to state which outcomes differed and which did not.
The current wording overstates null findings and is contradicted by the paper's own statistically significant result.
7.
HIGHethics
Add an explicit statement of adherence to a recognised regulatory framework (Declaration of Helsinki and/or ICH-GCP) via an erratum or the repository study record; the named ethics approvals and consent are present, but the compliance statement is missing.
The ethics dimension is currently incomplete because the regulatory-compliance sub-criterion is not reported, a fixable reporting gap.
8.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub with a Zenodo DOI) and update the Data availability statement to cite it; supplementary-material code lacks version control and a persistent identifier.
The data are openly available with a DOI, but the code that produced the results is not persistently citable, limiting reproducibility.
9.
HIGHstatistics
Verify every remaining Table 2 row for internal consistency (CI contains the estimate; CI excluding zero implies P<0.05; correct effect-measure labels) and publish one consolidated correction for all affected rows.
Multiple independent indicators of error in a single table raise the possibility of additional transcription or output errors that a systematic re-check would catch.
10.
MEDIUMreporting
Add an explicit CONSORT statement and a completed CONSORT checklist (e.g., in supplementary or repository records); a flow diagram alone is not a checklist.
The reporting-guideline sub-criterion is not met, though the trial flow diagram suggests practical adherence to CONSORT.
11.
MEDIUMreporting
Report race/ethnicity and a full comorbidity profile in the baseline table or supplementary material, or explicitly justify their omission.
The demographics sub-criterion is currently only partially reported, and completeness would strengthen the baseline comparability assessment.
12.
MEDIUMcopyedit
Fix the copyediting errors in a correction: 'analyse' not 'analysis', 'Clavien-Dindo' not 'Clavin-Dindo', 'oncological' not 'ontological', remove the double period in the Outcomes section, change 'were' to 'was' for 'the probability of surgical success', restore 'of' in 'probability of success', and complete the Table 2 footnote sentence.
These errors, while minor, reduce the paper's professional quality and one misnames a standard surgical complication classification system.
13.
LOWother
Verify and clarify the network-latency standard deviations (e.g., 47.5 (SD 0.08) ms, 22.8 (0.05) ms): SDs of ~0.05–0.08 ms around means of 20–50 ms are implausibly precise; check units and correct the reported dispersion.
Implausibly precise dispersion values may indicate a unit or typographical error and invite reader distrust of the technical measurements.

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Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.

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DOI

10.1136/bmj-2024-083588

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Issued Aug 10, 2026Engine 7.29.0

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Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×6−3★
ClaimsOverstated claim−0.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Biggest issues

01Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The NASA-TLX surgeon workload adjusted mean difference is −6.26 with 95% CI (−31.52 to −6.41); the point estimate is 0.15 units below the upper CI bound and 25 units above the lower bound, which is not credible for a standard 95% CI and suggests an error in either the estimate or the interval.
“The task load scores of surgeons in the telesurgery and local surgery groups were 29.0 and 48.0, respectively (adjusted mean difference −6.26, 95% CI −31.52 to −6.41; P=0.004; adjusted Cohen’s d=−0.93).”
Table 2Find in source
02Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
The QoR-15 6-week adjusted mean difference has 95% CI (0.94 to 31.82), which excludes zero, yet the reported P is 0.06; a 95% CI excluding zero implies a two-sided p<0.05.
“6 weeks | 147.0 (140.0-150.0) | 149.0 (144.0-150.0) | 8.18 (0.94 to 31.82) | 0.53 | 0.06”
Table 2Find in source
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.
“Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.”
AbstractFind in source
04Methods and results do not match
mediumAuthenticityreviewer-assessedFull detail
The complications row lists 'odds ratio 0.031 (−0.03 to 0.09)', but an odds ratio cannot have a negative lower bound; the interval is that of a risk difference, and the footnote attributes the calculation to Fisher's exact test, which would yield p≈1.0 for 1/31 vs 0/31, not the reported P=0.61.
“No (%) complications and adverse events | 1/31 (3) | 0 | 0.031 (−0.03 to 0.09) | 0.03 | 0.61”
Table 2Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 203AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

Numerical inconsistencies

1 finding · worst medium

Internal contradictions in the reported numbersAssessed

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

2 findings · worst medium

Conclusions overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

2 findings · worst medium

Methods and results do not matchAssessed
Implausibly large reported effectAssessed

6 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst medium

Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 2 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear scientific rationale for testing telesurgery reliability, cites prior feasibility work, and explicitly identifies the gap this RCT addresses.

Evidence

paraphrase[Introduction]

“Despite these prospects, the clinical validity of telesurgery remains unproved.”

IntroductionFind in source

PASSReviewer 2· 90% conf

Evidence

“Early milestone, such as the 2001 trans-Atlantic cholecystectomy, prioritised technical novelty over clinical rigour.”

Introduction ¶2Find in source

Introduction ¶3Find in source

“As this study is the first randomised controlled trial of telesurgery, no established reports were available for reference for determining the non-inferiority margin.”

MethodsFind in source

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· 90% conf

Evidence

“The participants were randomly assigned in a 1:1 ratio to undergo either telesurgery or standard local robotic surgery, using stratified randomisation with random block sizes of four.”

Randomisation and maskingFind in source

“Assuming a 10% attrition rate, we determined that a sample size of 34 participants per group was needed.”

Sample size calculationFind in source

“Participants, follow-up specialists (independent research nurses or doctors), and independent statisticians were masked to the form of surgery performed (telesurgery or local surgery).”

Randomisation and maskingFind in source

PASSReviewer 2· 95% conf

Evidence

“The participants were randomly assigned in a 1:1 ratio to undergo either telesurgery or standard local robotic surgery, using stratified randomisation with random block sizes of four.”

MethodsFind in source

“As masking of the medical team was not feasible, the determination of surgical success was conducted by the surgical team according to pre-specified criteria to minimise subjectivity.”

MethodsFind in source

paraphrase[Methods, Sample size calculation]

“The unilateral α value was set at 0.025, and the power (1−β) was set at 0.8. ... Assuming a 10% attrition rate, we determined that a sample size of 34 participants per group was needed.”

Sub-criteria

demographicsINADEQUATE

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· 75% conf

Sex, age, weight, BMI, and clinical characteristics are reported in the baseline table; race/ethnicity is not reported, but other demographics and health variables are adequate for a clinical trial.

Evidence

“Male sex, total | 28 (78) | 26 (72)”

Table 1Find in source

“Median (IQR) age, years | 61.0 (57.5-68.0) | 65.0 (56.5-70.0)”

Table 1Find in source

absence[Table 1]

Race/ethnicity is not reported in baseline characteristics.

PASSReviewer 2· 75% conf

Sex and age/weight/BMI are well reported, and demographics are largely covered, though race/ethnicity and a full comorbidity list are not explicitly provided (likely in supplementary).

Evidence

“Male sex, total | 28 (78) | 26 (72) | 24 (75) | 22 (71) |”

Table 1Find in source

“Median (IQR) age, years | 61.0 (57.5-68.0) | 65.0 (56.5-70.0) | 61.0 (57.5-68.0) | 62.0 (53.0-70.5) |”

Table 1Find in source

paraphrase[Table 1]

“Demographics listed include sex, age, height, weight, BMI, tumour characteristics, and patient location, but no race/ethnicity or comorbidity detail is given in the main table.”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Named ethics approval and informed consent are reported, but no explicit regulatory-compliance statement (e.g., Declaration of Helsinki or ICH-GCP) is provided.

Evidence

“This study was approved by the ethical review committee of Chinese PLA General Hospital (ID:2023-021) and the other four clinical trial sites.”

EthicsFind in source

“Participants signed a surgical informed consent and a separate research consent before enrolment.”

EthicsFind in source

absence[Ethics statements]

No regulatory compliance framework is stated.

WARNReviewer 2· 80% conf

Ethics approval and informed consent are adequately reported, but the paper does not explicitly state compliance with a recognised regulatory framework (e.g., Declaration of Helsinki).

Evidence

“This study was approved by the ethical review committee of Chinese PLA General Hospital (ID:2023-021) and the other four clinical trial sites.”

EthicsFind in source

“Participants signed a surgical informed consent and a separate research consent before enrolment.”

EthicsFind in source

absence[Ethics statements]

No explicit regulatory compliance statement (e.g., Declaration of Helsinki) is found.

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 device (MP1000 surgical robotic system) and statistical/visualization software are identified with manufacturer/version; bench-resource criteria are not applicable.

Evidence

“We used a four arm, multi-port Surgical Robotic System (MP1000, Edge Medical Co, Shenzhen, China) as the robotic subsystem.”

Telesurgery system structureFind in source

“We used SAS version 9.4 or RStudio for analyses.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational robotic system is identified (MP1000, Edge Medical Co) and analysis software is named with versions; no wet-lab reagents are used, so those criteria are not applicable.

Evidence

“We used a four arm, multi-port Surgical Robotic System (MP1000, Edge Medical Co, Shenzhen, China) as the robotic subsystem.”

MethodsFind in source

“We used SAS version 9.4 or RStudio for analyses.”

Statistical analysisFind in source

paraphrase[Methods]

“The study involves only surgical procedures and no cell lines, antibodies, or mycoplasma testing.”

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· 75% conf

Evidence

Statistical analysisFind in source

“All tests were two tailed with significance level α=0.05.”

Statistical analysisFind in source

“We used SAS version 9.4 or RStudio for analyses.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Evidence

“We used Fisher’s exact test to analysis the risk difference of the Clavin-Dindo complications without stratification.”

Statistical analysisFind in source

paraphrase[Table 2]

“P=0.87; P=0.41; P=0.82; P=0.67; P=0.48; P=0.10; P=0.65; P=0.06; P=0.24; P=0.77; P=0.41; P=0.35; P=0.12; P=0.004; P=0.83; P=0.70; P=0.07; P=0.61”

paraphrase[Table 2]

“Adjusted mean difference 13.67 (95% CI −25.22 to 29.61; P=0.87; adjusted Cohen’s d=0.05)”

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at Dryad: https://doi.org/10.5061/dryad.t4b8gtjg8 .”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at Dryad: https://doi.org/10.5061/dryad.t4b8gtjg8 .”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Reporting is generally transparent: trial registration, funding/COI, limitations, and proportional conclusions are present; the only gap is no explicit CONSORT checklist statement.

Evidence

“Trial registration ChiCTR.org ChiCTR2300077721.”

AbstractFind in source

paraphrase[Discussion]

absence[Methods]

No explicit CONSORT statement is present.

PASSReviewer 2· 85% conf

Evidence

“Trial registration ChiCTR.org ChiCTR2300077721.”

AbstractFind in source

“Firstly, clinical adoption of telesurgery remains limited, and a notable proportion of trial participants were recruited from non-local regions.”

LimitationsFind in source

paraphrase[Funding and Competing interests]

“Funding: This study was supported by grants from National Natural Science Foundation of China (M-0735)... Competing interests: All authors have completed the ICMJE uniform disclosure form...”

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

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 34 references by DOI: 33 verified — 1 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

13 copyedit issues flagged (4 major): mostly consistency, typo, punctuation.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHstatistics
Recompute and correct the QoR-15 6-week row in Table 2 (and the corresponding Results text): the reported 95% CI (0.94–31.82) excludes zero, which cannot coexist with P=0.06; publish a correction with a mutually consistent CI and P.
A 95% CI excluding zero implies two-sided P<0.05, so the reported pair is mathematically impossible and misleads readers about a secondary endpoint.
2.
HIGHstatistics
Correct the NASA-TLX surgeon workload row in Table 2: the point estimate (−6.26) lies outside its own 95% CI (−31.52 to −6.41); re-verify the estimate and interval and correct both in a correction.
A CI that does not contain its point estimate is impossible for a standard confidence interval and signals an output or transcription error.
3.
HIGHstatistics
Re-label and re-compute the complications effect measure in Table 2: an 'odds ratio' with a negative lower bound (−0.03 to 0.09) is impossible; if it is a risk difference, label it as such and recompute the P value, since a Fisher's exact test on the stated counts would not yield P=0.61.
The negative lower bound and the method/result mismatch make the reported effect measure invalid as printed.
4.
HIGHstatistics
Reconcile the positive surgical margin denominator in Table 2 (5/32) with the per-protocol local group size (n=31) and the Discussion's 16.1% (5/31), and state the correct fraction in a correction.
An inconsistent denominator in a reported event count undermines confidence in the oncological/complication outcomes.
5.
HIGHstatistics
Clarify the local-group failure count: the text says only one failure was observed in the local surgery group, but the ITT table reports 34/36 success (two failures); state explicitly whether one failure was imputed for a missing outcome and align the wording.
The text and table disagree about a primary-outcome event count, which is essential to interpreting the non-inferiority result.
6.
HIGHreporting
Temper the Abstract's claim that secondary outcomes 'did not differ substantially': surgeon workload differed significantly (NASA-TLX P=0.004), so revise the sentence to state which outcomes differed and which did not.
The current wording overstates null findings and is contradicted by the paper's own statistically significant result.
7.
HIGHethics
Add an explicit statement of adherence to a recognised regulatory framework (Declaration of Helsinki and/or ICH-GCP) via an erratum or the repository study record; the named ethics approvals and consent are present, but the compliance statement is missing.
The ethics dimension is currently incomplete because the regulatory-compliance sub-criterion is not reported, a fixable reporting gap.
8.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub with a Zenodo DOI) and update the Data availability statement to cite it; supplementary-material code lacks version control and a persistent identifier.
The data are openly available with a DOI, but the code that produced the results is not persistently citable, limiting reproducibility.
9.
HIGHstatistics
Verify every remaining Table 2 row for internal consistency (CI contains the estimate; CI excluding zero implies P<0.05; correct effect-measure labels) and publish one consolidated correction for all affected rows.
Multiple independent indicators of error in a single table raise the possibility of additional transcription or output errors that a systematic re-check would catch.
10.
MEDIUMreporting
Add an explicit CONSORT statement and a completed CONSORT checklist (e.g., in supplementary or repository records); a flow diagram alone is not a checklist.
The reporting-guideline sub-criterion is not met, though the trial flow diagram suggests practical adherence to CONSORT.
11.
MEDIUMreporting
Report race/ethnicity and a full comorbidity profile in the baseline table or supplementary material, or explicitly justify their omission.
The demographics sub-criterion is currently only partially reported, and completeness would strengthen the baseline comparability assessment.
12.
MEDIUMcopyedit
Fix the copyediting errors in a correction: 'analyse' not 'analysis', 'Clavien-Dindo' not 'Clavin-Dindo', 'oncological' not 'ontological', remove the double period in the Outcomes section, change 'were' to 'was' for 'the probability of surgical success', restore 'of' in 'probability of success', and complete the Table 2 footnote sentence.
These errors, while minor, reduce the paper's professional quality and one misnames a standard surgical complication classification system.
13.
LOWother
Verify and clarify the network-latency standard deviations (e.g., 47.5 (SD 0.08) ms, 22.8 (0.05) ms): SDs of ~0.05–0.08 ms around means of 20–50 ms are implausibly precise; check units and correct the reported dispersion.
Implausibly precise dispersion values may indicate a unit or typographical error and invite reader distrust of the technical measurements.

Full text (49,688 chars)Analyzed: Aug 10, 2026