Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.

Name: Kaimen Rigor review — Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.
Item: Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.
Rating: 96
Author: Alpha1

Bradbury AW, Hall JA, Popplewell MA, Meecham L, Bate GR, Kelly L, Deeks JJ, Moakes CA, BASIL-3 Investigators

Paper source

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Kaimen Rigor review — 3.75★ (Adequate), 0 critical, 2 high issues for “Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.”

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

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Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.

Bradbury AW, Hall JA, Popplewell MA, Meecham L, Bate GR, Kelly L, Deeks JJ, Moakes CA, BASIL-3 Investigators

Read full text (PMC)

DOI

10.1136/bmj-2024-080881

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.

Bradbury AW, Hall JA, Popplewell MA, Meecham L, Bate GR, Kelly L, Deeks JJ, Moakes CA, BASIL-3 Investigators

Paper source

Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

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

Kaimen Rigor review

Kaimen Rigor reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit4 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-conducted and well-reported phase 3 randomised controlled trial with a clear scientific premise, rigorous design, and comprehensive reporting of ethics, biological variables, and statistical methods. The main weakness is the vague data availability statement, which lacks a concrete access mechanism or platform. Minor copyedit issues and a few internal consistency points (e.g., 481 vs 480 participants) are noted but are explained in the text.

This is a post-publication audit of a published trial. Both reviewers independently scored all eight dimensions and agreed on all statuses, so no divergence needed reconciliation. The statistics verification component checked only 2 reported tests (both consistent); the rest of the statistical analyses were not machine-verified and should not be assumed correct. The citation check found no retracted or unresolved references.

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 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

1 finding · worst low

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 only partially backed by the presented evidenceAssessed

5 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.

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

Data authenticity concerns

None found

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.

Checked — nothing surfaced.

Reporting gaps

1 finding · 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

Eight Dimensions7 pass · 1 warn

The introduction cites three prior publicly funded RCTs (BASIL, BEST-CLI, BASIL-2) and notes the uncertainty about the relative effectiveness of PBA, DCBA, and DES, supported by systematic reviews and guidelines. The rationale is logical: NICE recommended a trial, leading to NIHR HTA funding. The paper acknowledges limitations of prior work (e.g., many studies analysed DCBA and DES together) and addresses them by comparing the three strategies separately.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior randomised trials and guidelines, and provides a logical rationale for the trial.

Evidence

“To date, three published, publicly funded randomised controlled trials have compared the clinical and cost effectiveness of different revascularisation strategies in chronic limb threatening ischaemia.”

Introduction ¶2Find in source

“In 2012, the UK National Institute for Health and Care Excellence (NICE) recommended a randomised controlled trial to compare the clinical and cost effectiveness of PBA, BMS, DCBA, and DES in patients with chronic limb threatening ischaemia.”

Introduction ¶3Find in source

“Unlike BASIL-3, many studies analysed DCBA and DES together, even though they are very different technologies with their own advantages and disadvantages in different clinical and anatomic scenarios.”

DiscussionFind in source

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior randomised trials (BASIL, BEST-CLI, BASIL-2) and systematic reviews, and justifies the need for the trial based on NICE recommendations and existing evidence gaps.

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

DiscussionFind in source

Randomisation was performed using a secure online system with minimisation to balance key prognostic variables. The sample size calculation is detailed, including a correction for an error in the original macro. Inclusion/exclusion criteria are pre-specified. Blinding was not used, but the trial is open-label by design, which is appropriate for a device trial. The analysis populations (intention-to-treat and per-protocol) are defined. Outlier handling is addressed through the pre-specified analysis population and missing data approach.

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: randomisation method, minimisation, sample size calculation, inclusion/exclusion criteria, and analysis populations are all clearly described.

Evidence

paraphrase[Methods, Randomisation and masking]

“Participants were randomly assigned (1:1:1) using a secure online system to femoro-popliteal PBA±BMS, DCBA±BMS, or DES as their first revascularisation procedure. Minimisation was used to balance assignments according to age, sex, diabetes mellitus, chronic kidney disease, severity of clinical disease, previous (permissible) intervention to the trial leg, target artery, intention for a hybrid procedure, and recruiting centre.”

“Allowing for 5% attrition and the BASIL-1 survival estimates, 861 participants (having 342 primary outcome events) would provide 90% power to detect a reduction in amputation free survival of 40% (hazard ratio 0.60, equivalent to an absolute difference in amputation free survival of 13% at year 2, corresponding to one out of seven participants needing to benefit from DES or DCBA over PBA (number needed to treat) at the 2.5% significance level (to account for increased type I error risk associated with making two key comparisons) using the artsurv (version 1.0.7) programme in Stata (version 17.0). However, an error was identified in the implementation of the macro used to compute the original sample size, whereby a smaller effect size (than the targeted 40% relative reduction) had been applied for one of the two comparisons. This resulted in an overestimation of the sample size and number of primary outcome events needed. Using the same parameters as in the original calculation (listed above), the corrected sample size was 749 and the number of primary outcome events required was 291.”

Statistical analysisFind in source

“Patients were excluded if they were expected to live for less than six months (pragmatic decision by randomising team) or had undergone an intervention to the target femoro-popliteal vessel within the past 12 months.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: central randomisation with minimisation, clear inclusion/exclusion criteria, a pre-specified statistical analysis plan, and appropriate handling of the analysis population. Blinding was not feasible (open-label) but is stated with rationale.

Evidence

“Participants were randomly assigned (1:1:1) using a secure online system to femoro-popliteal PBA±BMS, DCBA±BMS, or DES as their first revascularisation procedure.”

MethodsFind in source

“Participants, study staff, and investigators were not masked to treatment allocation.”

MethodsFind in source

“However, an error was identified in the implementation of the macro used to compute the original sample size, whereby a smaller effect size (than the targeted 40% relative reduction) had been applied for one of the two comparisons.”

Statistical analysisFind in source

Sex is reported for all participants (167 women, 35%). Age is reported as mean and SD, and also categorised. Demographics include ethnicity, smoking status, comorbidities, and mobility. Since both sexes are included, sex_justified is not applicable. 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

Demographic and clinical characteristics are comprehensively reported, including sex, age, and comorbidities.

Evidence

“481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)).”

AbstractFind in source

“Table 1 Baseline characteristics by randomised group”

Table 1Find in source

PASSReviewer 2· 95% conf

The trial reports sex, age, and other demographics comprehensively. Since both sexes are enrolled, a justification for single-sex is not applicable. Species/strain and housing conditions are not applicable for a human trial.

Evidence

“Of the 480 participants included in the analyses, 167 (35%) were women, and the mean age was 71.8 years (standard deviation 10.8; , ).”

Results ¶1Find in source

paraphrase[Table 1]

“Ethnicity | White | 151 (94) | 151 (94) | 149 (93)”

The paper states ethical approval was obtained from the National Research Ethics Committee, North of Scotland, on 26 August 2015 (15/NS/0070). Informed consent is described (written informed consent was required; one participant was removed for lack of consent). Compliance with the Declaration of Helsinki and Good Clinical Practice guidelines is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named committee and informed consent are documented, along with regulatory compliance.

Evidence

“The National Research Ethics Committee, North of Scotland, provided ethical approval on 26 August 2015 (15/NS/0070).”

MethodsFind in source

“Additionally, they needed to speak sufficient English (where translation facilities were insufficient) and to have capacity to provide written informed consent.”

MethodsFind in source

“Declaration of Helsinki and Good Clinical Practice guidelines were followed.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial has a named ethics committee approval with protocol number, and informed consent is described. Regulatory compliance with Declaration of Helsinki and GCP is stated.

Evidence

“The National Research Ethics Committee, North of Scotland, provided ethical approval on 26 August 2015 (15/NS/0070).”

MethodsFind in source

“Additionally, they needed to speak sufficient English (where translation facilities were insufficient) and to have capacity to provide written informed consent.”

MethodsFind in source

“Declaration of Helsinki and Good Clinical Practice guidelines were followed.”

MethodsFind in source

The trial uses drug-coated balloons and drug-eluting stents as investigational products. The paper names the device classes and states that any UK licensed PBA, DCBA, BMS, or DES was permitted, but does not specify manufacturers or lot numbers, which is typical for a pragmatic trial. Statistical software (SAS, Stata) is identified with versions. Antibodies, cell lines, mycoplasma, and organisms are not applicable.

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 devices are identified as classes (PBA, DCBA, DES) with the allowance of any UK licensed device, which is adequate for a pragmatic trial.

Evidence

“Any UK licensed PBA, DCBA, BMS, or DES was permitted.”

MethodsFind in source

“All analyses were done in SAS (version 9.4) or Stata (version 18.0).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (PBA, DCBA, DES) are identified as classes of devices, and the paper states that any UK licensed device was permitted. Software used for analysis is identified.

Evidence

“Any UK licensed PBA, DCBA, BMS, or DES was permitted.”

MethodsFind in source

“All analyses were done in SAS (version 9.4) or Stata (version 18.0).”

Statistical analysisFind in source

The primary analysis uses Cox proportional hazards models with adjusted hazard ratios and 97.5% confidence intervals. Secondary outcomes use appropriate methods (competing risks, mixed models, GEE). Exact p-values are reported for the primary outcome. Effect sizes are reported with confidence intervals. Software is identified. Data presentation follows clinical trial conventions (Kaplan-Meier curves, CONSORT diagram). Mathematical plausibility checks are not applicable due to large sample size and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are comprehensive and appropriate for a clinical trial, with pre-specified analyses, effect sizes with confidence intervals, and software identified.

Evidence

“Amputation free survival was analysed using a Cox proportional hazards model to generate an adjusted hazard ratio.”

Statistical analysisFind in source

“HR 0.84 (0.61 to 1.16),† P=0.22”

Table 3Find in source

“HR 0.84 (0.61 to 1.16),† P=0.22”

Table 3Find in source

PASSReviewer 2· 90% conf

Statistical methods are thoroughly described, including tests, models, and software. Effect sizes are reported with confidence intervals, and p-values are exact for the primary outcome. Data presentation follows clinical trial conventions.

Evidence

“Amputation free survival was analysed using a Cox proportional hazards model to generate an adjusted hazard ratio.”

Statistical analysisFind in source

“adjusted hazard ratio from the Cox proportional hazards model 0.84; 97.5% confidence interval 0.61 to 1.16; P=0.22”

Results ¶2Find in source

“adjusted hazard ratio 0.86, 97.5% confidence interval 0.62 to 1.20”

Results ¶2Find in source

The data availability statement says 'Requests for data should be directed to the corresponding author. Participant level data will be made available within six months of publication. Requests will be assessed for scientific rigour before being granted. Data will be anonymised and securely transferred. A data sharing agreement might be required.' This is more concrete than a bare 'on request' but lacks a named platform or data access committee. Repository deposit and accession numbers are not applicable for patient-level data. Code sharing is not applicable as no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, lacking a concrete access mechanism or platform.

Evidence

“Requests for data should be directed to the corresponding author. Participant level data will be made available within six months of publication. Requests will be assessed for scientific rigour before being granted. Data will be anonymised and securely transferred. A data sharing agreement might be required.”

Data availabilityFind in source

WARNReviewer 2· 90% conf

A data availability statement is present but vague, stating that requests should be directed to the corresponding author without specifying a concrete mechanism or timeframe. No code is shared.

Evidence

Data availabilityFind in source

The trial is registered (ISRCTN14469736). Methods are detailed enough for replication. A CONSORT diagram is included, indicating adherence to CONSORT. All pre-specified outcomes are reported, including negative results. Limitations are discussed extensively. Conclusions are proportional to the evidence. Funding and competing interests are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

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

Evidence

“ISRCTN registry ISRCTN14469736”

AbstractFind in source

“Fig 1 Consolidated standards of reporting trials (CONSORT) diagram.”

Figure 1Find in source

“Because of concerns about the safety of paclitaxel, BASIL-3 recruitment was paused between December 2018 and September 2019. Although we have no evidence to suggest that this was the case, we cannot exclude the possibility that patients recruited before and after the pause were different.”

LimitationsFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are detailed, limitations are discussed, conclusions are proportional, and funding and competing interests are declared. A reporting guideline (CONSORT) is referenced via the CONSORT diagram.

Evidence

“ISRCTN registry ISRCTN14469736”

AbstractFind in source

“Fig 1 Consolidated standards of reporting trials (CONSORT) diagram.”

Figure 1Find in source

“Because of concerns about the safety of paclitaxel, BASIL-3 recruitment was paused between December 2018 and September 2019.”

LimitationsFind in source

Registered (1 ID: ISRCTN). Reporting guideline cited: CONSORT.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 24 references by DOI: 23 verified — 1 no DOI (shown, not verified).

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the vague data availability statement and the minor internal consistency points (481 vs 480 participants) as minor limitations. No erratum or correction appears necessary, but the authors could improve transparency by providing a more concrete data access route and clarifying the participant count discrepancy.

1.
HIGHdata code
In the Data availability statement, specify a concrete access mechanism such as a named data access committee or a repository (e.g., YODA, Vivli) and detail the request process and timeline.
The current statement is vague and only directs requests to the corresponding author, which is a reporting gap that could hinder reproducibility.
2.
HIGHdata code
Consider depositing anonymised participant-level data in a recognised repository (e.g., a clinical trial data repository) and provide an accession number or DOI.
Depositing data in a repository would enhance transparency and allow independent verification, while respecting patient privacy.
3.
MEDIUMdata code
If bespoke analysis code was used, share it in a public repository (e.g., GitHub) with a DOI to allow independent verification of the statistical analyses.
Code sharing is currently not reported, and providing it would improve reproducibility.
4.
MEDIUMreporting
Clarify the discrepancy between 481 participants randomised (abstract) and 480 participants included in analyses (results) by explicitly stating that one participant was removed for lack of consent in the abstract or results section.
The internal contradiction is explained in the text but could confuse readers; making it explicit improves clarity.
5.
MEDIUMreporting
In Table 1, ensure the DES group n=159 is clearly footnoted as excluding the participant who did not provide consent, to avoid apparent inconsistency with the text stating 160 were randomised.
The footnote exists but could be more prominent to prevent misinterpretation.
6.
MEDIUMreporting
Add a statement about the availability of the statistical analysis plan (SAP) and any protocol amendments in the supplementary materials.
Providing the SAP would enhance transparency and allow readers to verify that analyses were pre-specified.
7.
MEDIUMreporting
Clarify the specific devices used in each arm (e.g., brand names) in the supplementary materials, as the paper only states that any UK licensed device was permitted.
Specifying devices would improve reproducibility and allow readers to assess generalisability.
8.
MEDIUMstatistics
Report the results of the flexible parametric model for non-proportional hazards in more detail, including the number of knots and model selection process.
This would enhance transparency of the sensitivity analysis and allow readers to assess its validity.
9.
LOWcopyedit
In Table 2, correct the typo 'Nether antiplatelet nor anticoagulant' to 'Neither antiplatelet nor anticoagulant'.
This is a minor typographical error that should be fixed for professionalism.
10.
LOWcopyedit
In Table 3, ensure the abbreviation expansion for PEDIS is consistent with the text (e.g., use 'perfusion, extent, depth, infection, and sensation' consistently).
Minor inconsistency in comma usage could be confusing.
11.
LOWcopyedit
In the Results section, clarify that the meta-analysis that prompted the recruitment pause was external and not part of this trial.
This improves clarity about the reason for the pause.
12.
LOWcopyedit
Ensure consistent use of 'participants' vs 'patients' throughout the manuscript.
Minor terminology inconsistency could be polished.

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Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.

Bradbury AW, Hall JA, Popplewell MA, Meecham L, Bate GR, Kelly L, Deeks JJ, Moakes CA, BASIL-3 Investigators

Read full text (PMC)

DOI

10.1136/bmj-2024-080881

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Record fingerprint

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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

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit4 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

5 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.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior randomised trials and guidelines, and provides a logical rationale for the trial.

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

DiscussionFind in source

PASSReviewer 2· 95% conf

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

DiscussionFind 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· 95% conf

The trial design is rigorous: randomisation method, minimisation, sample size calculation, inclusion/exclusion criteria, and analysis populations are all clearly described.

Evidence

paraphrase[Methods, Randomisation and masking]

Statistical analysisFind in source

MethodsFind in source

PASSReviewer 2· 95% conf

Evidence

“Participants were randomly assigned (1:1:1) using a secure online system to femoro-popliteal PBA±BMS, DCBA±BMS, or DES as their first revascularisation procedure.”

MethodsFind in source

“Participants, study staff, and investigators were not masked to treatment allocation.”

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

Demographic and clinical characteristics are comprehensively reported, including sex, age, and comorbidities.

Evidence

“481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)).”

AbstractFind in source

“Table 1 Baseline characteristics by randomised group”

Table 1Find in source

PASSReviewer 2· 95% conf

Evidence

“Of the 480 participants included in the analyses, 167 (35%) were women, and the mean age was 71.8 years (standard deviation 10.8; , ).”

Results ¶1Find in source

paraphrase[Table 1]

“Ethnicity | White | 151 (94) | 151 (94) | 149 (93)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named committee and informed consent are documented, along with regulatory compliance.

Evidence

“The National Research Ethics Committee, North of Scotland, provided ethical approval on 26 August 2015 (15/NS/0070).”

MethodsFind in source

“Additionally, they needed to speak sufficient English (where translation facilities were insufficient) and to have capacity to provide written informed consent.”

MethodsFind in source

“Declaration of Helsinki and Good Clinical Practice guidelines were followed.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial has a named ethics committee approval with protocol number, and informed consent is described. Regulatory compliance with Declaration of Helsinki and GCP is stated.

Evidence

“The National Research Ethics Committee, North of Scotland, provided ethical approval on 26 August 2015 (15/NS/0070).”

MethodsFind in source

“Additionally, they needed to speak sufficient English (where translation facilities were insufficient) and to have capacity to provide written informed consent.”

MethodsFind in source

“Declaration of Helsinki and Good Clinical Practice guidelines were followed.”

MethodsFind 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 devices are identified as classes (PBA, DCBA, DES) with the allowance of any UK licensed device, which is adequate for a pragmatic trial.

Evidence

“Any UK licensed PBA, DCBA, BMS, or DES was permitted.”

MethodsFind in source

“All analyses were done in SAS (version 9.4) or Stata (version 18.0).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (PBA, DCBA, DES) are identified as classes of devices, and the paper states that any UK licensed device was permitted. Software used for analysis is identified.

Evidence

“Any UK licensed PBA, DCBA, BMS, or DES was permitted.”

MethodsFind in source

“All analyses were done in SAS (version 9.4) or Stata (version 18.0).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are comprehensive and appropriate for a clinical trial, with pre-specified analyses, effect sizes with confidence intervals, and software identified.

Evidence

“Amputation free survival was analysed using a Cox proportional hazards model to generate an adjusted hazard ratio.”

Statistical analysisFind in source

“HR 0.84 (0.61 to 1.16),† P=0.22”

Table 3Find in source

“HR 0.84 (0.61 to 1.16),† P=0.22”

Table 3Find in source

PASSReviewer 2· 90% conf

Evidence

“Amputation free survival was analysed using a Cox proportional hazards model to generate an adjusted hazard ratio.”

Statistical analysisFind in source

“adjusted hazard ratio from the Cox proportional hazards model 0.84; 97.5% confidence interval 0.61 to 1.16; P=0.22”

Results ¶2Find in source

“adjusted hazard ratio 0.86, 97.5% confidence interval 0.62 to 1.20”

Results ¶2Find in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, lacking a concrete access mechanism or platform.

Evidence

Data availabilityFind in source

WARNReviewer 2· 90% conf

A data availability statement is present but vague, stating that requests should be directed to the corresponding author without specifying a concrete mechanism or timeframe. No code is shared.

Evidence

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

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

Evidence

“ISRCTN registry ISRCTN14469736”

AbstractFind in source

“Fig 1 Consolidated standards of reporting trials (CONSORT) diagram.”

Figure 1Find in source

LimitationsFind in source

PASSReviewer 2· 95% conf

Evidence

“ISRCTN registry ISRCTN14469736”

AbstractFind in source

“Fig 1 Consolidated standards of reporting trials (CONSORT) diagram.”

Figure 1Find in source

“Because of concerns about the safety of paclitaxel, BASIL-3 recruitment was paused between December 2018 and September 2019.”

LimitationsFind in source

Registered (1 ID: ISRCTN). Reporting guideline cited: CONSORT.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 24 references by DOI: 23 verified — 1 no DOI (shown, not verified).

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
In the Data availability statement, specify a concrete access mechanism such as a named data access committee or a repository (e.g., YODA, Vivli) and detail the request process and timeline.
The current statement is vague and only directs requests to the corresponding author, which is a reporting gap that could hinder reproducibility.
2.
HIGHdata code
Consider depositing anonymised participant-level data in a recognised repository (e.g., a clinical trial data repository) and provide an accession number or DOI.
Depositing data in a repository would enhance transparency and allow independent verification, while respecting patient privacy.
3.
MEDIUMdata code
If bespoke analysis code was used, share it in a public repository (e.g., GitHub) with a DOI to allow independent verification of the statistical analyses.
Code sharing is currently not reported, and providing it would improve reproducibility.
4.
MEDIUMreporting
Clarify the discrepancy between 481 participants randomised (abstract) and 480 participants included in analyses (results) by explicitly stating that one participant was removed for lack of consent in the abstract or results section.
The internal contradiction is explained in the text but could confuse readers; making it explicit improves clarity.
5.
MEDIUMreporting
In Table 1, ensure the DES group n=159 is clearly footnoted as excluding the participant who did not provide consent, to avoid apparent inconsistency with the text stating 160 were randomised.
The footnote exists but could be more prominent to prevent misinterpretation.
6.
MEDIUMreporting
Add a statement about the availability of the statistical analysis plan (SAP) and any protocol amendments in the supplementary materials.
Providing the SAP would enhance transparency and allow readers to verify that analyses were pre-specified.
7.
MEDIUMreporting
Clarify the specific devices used in each arm (e.g., brand names) in the supplementary materials, as the paper only states that any UK licensed device was permitted.
Specifying devices would improve reproducibility and allow readers to assess generalisability.
8.
MEDIUMstatistics
Report the results of the flexible parametric model for non-proportional hazards in more detail, including the number of knots and model selection process.
This would enhance transparency of the sensitivity analysis and allow readers to assess its validity.
9.
LOWcopyedit
In Table 2, correct the typo 'Nether antiplatelet nor anticoagulant' to 'Neither antiplatelet nor anticoagulant'.
This is a minor typographical error that should be fixed for professionalism.
10.
LOWcopyedit
In Table 3, ensure the abbreviation expansion for PEDIS is consistent with the text (e.g., use 'perfusion, extent, depth, infection, and sensation' consistently).
Minor inconsistency in comma usage could be confusing.
11.
LOWcopyedit
In the Results section, clarify that the meta-analysis that prompted the recruitment pause was external and not part of this trial.
This improves clarity about the reason for the pause.
12.
LOWcopyedit
Ensure consistent use of 'participants' vs 'patients' throughout the manuscript.
Minor terminology inconsistency could be polished.

Full text (61,453 chars)Analyzed: Aug 15, 2026