Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

Name: Kaimen Rigor review — Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.
Item: Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.
Rating: 96
Author: Alpha1

Kearney RS, Ellard DR, Parsons H, Haque A, Mason J, Nwankwo H, Bradley H, Drew S, Modi C, Bush H, Torgerson D, Underwood M, The ARTISAN collaborators, ARTISAN collaborators

Paper source

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Kaimen Rigor review — 3.75★ (Adequate), 0 critical, 2 high issues for “Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

Kearney RS, Ellard DR, Parsons H, Haque A, Mason J, Nwankwo H, Bradley H, Drew S, Modi C, Bush H, Torgerson D, Underwood M, The ARTISAN collaborators, ARTISAN collaborators

Read full text (PMC)

DOI

10.1136/bmj-2023-076925

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

Kearney RS, Ellard DR, Parsons H, Haque A, Mason J, Nwankwo H, Bradley H, Drew S, Modi C, Bush H, Torgerson D, Underwood M, The ARTISAN collaborators, ARTISAN collaborators

Paper source

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled 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 16, 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

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 16 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.
No data or code availability links were detected to verify.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 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-conducted and well-reported pragmatic RCT with rigorous randomisation, allocation concealment, pre-specified analysis, and appropriate handling of missing data. The main weaknesses are a vague data availability statement and minor reporting gaps (no explicit CONSORT statement, minor copyedit issues).

Both reviewers agreed on study type (interventional) and on all dimension statuses. The only divergence was on the limitations addressed sub-criterion in scientific premise (adequate vs. reported but inadequate) and reporting guideline (reported but inadequate vs. not reported), both resolved by weighing the evidence. Statistics verification covered only 5 tests (all consistent); the rest are unverified. 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 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.

Overstated conclusions

None found

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.

Checked — nothing surfaced.

7 major claims checked against the paper's own evidence: all adequately supported.

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 a 2019 population-based cohort and Cochrane reviews to establish the incidence and lack of evidence for rehabilitation methods. The rationale for comparing advice-only versus additional physiotherapy is clearly linked to the resource implications and the gap in evidence. The paper acknowledges the limitations of prior research, such as the 2014 Cochrane review finding no RCTs, and the 2019 update identifying only one ongoing study.

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 with prior work cited, a logical rationale, and addresses limitations of prior research.

Evidence

“A 2019 population based cohort of 16 763 people reported the incidence to be 40.4 per 100 000 person years in men and 15.5 in women.”

Introduction ¶1Find in source

“Despite the important role of rehabilitation for this common condition, evidence comparing different rehabilitation methods after the initial period in a sling is scarce.”

Introduction ¶3Find in source

“A 2014 Cochrane review on methods of non-operative management showed no randomised controlled trials comparing different rehabilitation methods after the initial two weeks of supporting the arm in a sling.”

DiscussionFind in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale linking the evidence gap to the trial objective.

Evidence

“A 2019 population based cohort of 16 763 people reported the incidence to be 40.4 per 100 000 person years in men and 15.5 in women.”

Introduction ¶1Find in source

“Considering the large personal and societal cost associated with this injury, the primary objective of the ARTISAN trial was to compare the clinical effectiveness of two rehabilitation interventions in adults with a first time traumatic shoulder dislocation.”

Introduction ¶3Find in source

“Despite the important role of rehabilitation for this common condition, evidence comparing different rehabilitation methods after the initial period in a sling is scarce.”

Introduction ¶2Find in source

Randomisation used a minimisation algorithm with a random element, stratified by centre, age, and arm dominance, with allocation concealment maintained by an independent team. Blinding of participants and clinicians was not possible, but this is acknowledged and the central team was masked. A power analysis was conducted, requiring 478 participants for 90% power. Inclusion/exclusion criteria were pre-specified, and the analysis population (ITT and per protocol) was defined. Outlier handling is addressed through multiple imputation for missing data.

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 with clear randomisation, allocation concealment, pre-specified analysis, and appropriate handling of blinding limitations.

Evidence

“Allocation concealment was maintained by an independent randomisation team at Warwick Clinical Trials Unit who were responsible for generation of the sequence and had no role in participant recruitment.”

MethodsFind in source

“As such, 478 participants were required to show a 4 point target difference (ie, a small, standardised mean difference of 0.3) at the 5% significance level, with 90% power, allowing a margin of 20% loss during follow-up.”

Statistical analysisFind in source

“Following randomisation, masking participants or treating clinicians to treatment allocation was not possible. However, the treating clinician and the participant were masked to treatment allocation during the initial advice session.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomisation, allocation concealment, pre-specified analysis, and a power calculation.

Evidence

MethodsFind in source

“Following randomisation, masking participants or treating clinicians to treatment allocation was not possible.”

MethodsFind in source

Statistical analysisFind in source

Sex is reported (66% male), age is reported (mean 45 years), and demographics such as race/ethnicity, employment, and comorbidities are detailed in Table 1. 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.

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 well reported, including sex, age, and other relevant variables.

Evidence

“Participants were mostly male (66%, n=317), with a mean age of 45 years.”

ResultsFind in source

“Race and ethnicity/ancestry†: | | Asian | 18 (8) | 19 (8) | 37 (8) |”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and health status.

Evidence

“Participants were mostly male (66%, n=317), with a mean age of 45 years.”

ResultsFind in source

“Race and ethnicity/ancestry†: | | Asian | 18 (8) | 19 (8) | 37 (8) |”

Table 1Find in source

The study reports approval from the National Research Ethics Committee with a protocol number (18/WA/0236) and individual NHS Trust approvals. Written informed consent is described. Regulatory compliance is implied through adherence to NHS research governance.

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 ethics committee and informed consent are clearly documented.

Evidence

“The national research ethics committee approved this study on 26 July 2018 (18/WA/0236), with each trial site granting individual NHS Trust approval before recruitment at each site.”

MethodsFind in source

“After assessment, potential participants were provided with verbal and written information before they provided written informed consent.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The national research ethics committee approved this study on 26 July 2018 (18/WA/0236)”

MethodsFind in source

“After assessment, potential participants were provided with verbal and written information before they provided written informed consent.”

MethodsFind in source

The interventions (advice session and additional physiotherapy) are described with details on duration, content, and delivery. The statistical software R (version 4.0.3) is identified. No antibodies, cell lines, or other biological reagents are used, so those criteria 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 interventions are described in sufficient detail, and the statistical software is identified.

Evidence

“Analyses were conducted in R (version 4.0.3)”

Statistical analysisFind in source

“Each additional session lasted for up to 30 min, over a maximum duration of four months from the date of randomisation.”

MethodsFind in source

PASSReviewer 2· 85% conf

The investigational interventions are adequately described, and statistical software is identified.

Evidence

“All participants had an initial period in which the injured arm was supported in a sling and then received an appointment for a physiotherapy advice session within six weeks of their injury.”

MethodsFind in source

“Analyses were conducted in R (version 4.0.3)”

Statistical analysisFind in source

The primary analysis used mixed effects linear regression, with adjustment for stratification variables. Exact p-values are reported in Tables 2 and 3. Effect sizes are reported with 95% confidence intervals. The software (R) is identified. Data presentation includes per-group n, means, and SDs. Mathematical plausibility checks were not performed due to continuous outcomes and large N, but no obvious inconsistencies were noted.

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 appropriate and well-reported, with exact p-values and confidence intervals for effect sizes.

Evidence

“Unadjusted and adjusted mixed effects linear regression models were used to estimate the between group difference.”

Statistical analysisFind in source

“6 months | 180 | 36.2 (10.7) | 174 | 38.4 (9.2) | 1.5 (−0.3 to 3.5) | 0.11”

Table 2Find in source

“between group difference favouring physiotherapy 1.5 (95% confidence interval −0.3 to 3.5)”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well reported, with exact p-values and confidence intervals.

Evidence

“Unadjusted and adjusted mixed effects linear regression models were used to estimate the between group difference.”

Statistical analysisFind in source

“0.7 (−1.0 to 2.4) | 0.44”

Table 2Find in source

“between group difference favouring physiotherapy 1.5 (95% confidence interval −0.3 to 3.5)”

AbstractFind in source

The data availability statement says requests should be submitted to an email address for consideration, but does not specify conditions or a timeframe. This is a managed-access route but lacks detail, making it 'reported_but_inadequate'. No repository deposit or accession numbers are provided, which is acceptable for patient-level data, but the statement could be more concrete.

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 clear mechanism or timeframe for access.

Evidence

“All data requests should be submitted to WCTUDataAccess@warwick.ac.uk for consideration. Access to anonymised data may be granted following review.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement is present but vague, lacking a clear mechanism or timeframe.

Evidence

“All data requests should be submitted to WCTUDataAccess@warwick.ac.uk for consideration. Access to anonymised data may be granted following review.”

Data availabilityFind in source

The trial is registered with ISRCTN63184243. Methods are detailed enough for replication. Limitations are discussed, including loss to follow-up. Conclusions are proportional to the results, noting no superiority of additional physiotherapy. Funding and competing interests are declared.

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· 95% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“Trial registration Current Controlled Trials ISRCTN63184243.”

AbstractFind in source

“The main limitation was the 27% loss to follow up, however, the observed standard deviation was much smaller than anticipated.”

LimitationsFind in source

“Funding: This trial was funded by the National Institute for Health and Care Research (16/167/56), 01/06/18.”

FundingFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“Trial registration Current Controlled Trials ISRCTN63184243.”

AbstractFind in source

“The main limitation was the 27% loss to follow up”

LimitationsFind in source

“This trial was funded by the National Institute for Health and Care Research (16/167/56), 01/06/18.”

FundingFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

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 15 references by DOI: 15 verified.

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 trustworthy; an informed reader should weigh the minor data-access vagueness and the absence of an explicit CONSORT statement as minor transparency limitations, not validity threats. No erratum is warranted for the copyedit issues, though the Table 3 CI typo could be corrected in a future erratum.

1.
HIGHdata code
In the Data availability statement, specify the conditions and timeframe for data access, e.g., 'Requests will be reviewed within 30 days and data will be shared after approval and a data sharing agreement.'
The current statement is vague and does not meet common transparency expectations for a data-driven trial.
2.
HIGHreporting
In the Methods or Acknowledgments, explicitly state adherence to the CONSORT reporting guideline.
The paper follows CONSORT-like structure but does not explicitly confirm adherence, which is a standard expectation for RCTs.
3.
MEDIUMreporting
In the Methods, add a link to the statistical analysis plan (Supplement 1) for transparency.
Providing a direct link improves reproducibility and reviewer confidence.
4.
MEDIUMreporting
In the Methods, clarify the role of the data monitoring committee and trial steering committee.
Enhances governance transparency for a multicentre trial.
5.
MEDIUMcopyedit
In Table 3, correct the EQ-5D-5L confidence interval from '0.009 (−0.26 to 0.047)' to '0.009 (−0.026 to 0.047)'.
The current CI has inconsistent decimal places and appears to be a typographical error.
6.
MEDIUMcopyedit
In the Acknowledgments, correct the misspelled names 'Fracnesca Gowing' to 'Francesca Gowing' and 'Lynn Osbome' to 'Lynn Osborne'.
Misspelling collaborator names is unprofessional and should be fixed.
7.
LOWcopyedit
In Results, Participants and adherence, change '81% (n=194) of 240 participants receiving advice only' to '81% (n=194) of 240 participants received advice only'.
Verb tense inconsistency reduces readability.
8.
LOWcopyedit
In Discussion, Principal findings, change 'We did not report a difference' to 'We did not find a difference'.
Awkward phrasing; 'find' is more natural.
9.
LOWcopyedit
In Discussion, Comparison with other studies, consider splitting the long sentence about the supervised physiotherapy group for clarity.
Long sentences reduce readability.
10.
LOWdata code
Consider depositing the statistical analysis plan and any non-identifiable aggregate data in a public repository (e.g., Zenodo) with a DOI.
Would further improve transparency and reproducibility.
11.
LOWdata code
Include a statement on the availability of the statistical analysis code, even if on request.
Clarifies code availability and supports reproducibility.

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Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

Kearney RS, Ellard DR, Parsons H, Haque A, Mason J, Nwankwo H, Bradley H, Drew S, Modi C, Bush H, Torgerson D, Underwood M, The ARTISAN collaborators, ARTISAN collaborators

Read full text (PMC)

DOI

10.1136/bmj-2023-076925

Share this Kaimen Rigor review

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Record fingerprint

44324c1a3a60430f8d7f3d221cb89e1b9ae22cfea06bb8a2d7e95e1504416a2c

Verify via API

Issued Aug 16, 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

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 16 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.
No data or code availability links were detected to verify.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit6 minor suggestions

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

None found

Checked — nothing surfaced.

7 major claims checked against the paper's own evidence: all adequately supported.

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 with prior work cited, a logical rationale, and addresses limitations of prior research.

Evidence

“A 2019 population based cohort of 16 763 people reported the incidence to be 40.4 per 100 000 person years in men and 15.5 in women.”

Introduction ¶1Find in source

“Despite the important role of rehabilitation for this common condition, evidence comparing different rehabilitation methods after the initial period in a sling is scarce.”

Introduction ¶3Find in source

DiscussionFind in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale linking the evidence gap to the trial objective.

Evidence

“A 2019 population based cohort of 16 763 people reported the incidence to be 40.4 per 100 000 person years in men and 15.5 in women.”

Introduction ¶1Find in source

Introduction ¶3Find in source

“Despite the important role of rehabilitation for this common condition, evidence comparing different rehabilitation methods after the initial period in a sling is scarce.”

Introduction ¶2Find 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 with clear randomisation, allocation concealment, pre-specified analysis, and appropriate handling of blinding limitations.

Evidence

MethodsFind in source

Statistical analysisFind in source

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomisation, allocation concealment, pre-specified analysis, and a power calculation.

Evidence

MethodsFind in source

“Following randomisation, masking participants or treating clinicians to treatment allocation was not possible.”

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 well reported, including sex, age, and other relevant variables.

Evidence

“Participants were mostly male (66%, n=317), with a mean age of 45 years.”

ResultsFind in source

“Race and ethnicity/ancestry†: | | Asian | 18 (8) | 19 (8) | 37 (8) |”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and health status.

Evidence

“Participants were mostly male (66%, n=317), with a mean age of 45 years.”

ResultsFind in source

“Race and ethnicity/ancestry†: | | Asian | 18 (8) | 19 (8) | 37 (8) |”

Table 1Find in source

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 ethics committee and informed consent are clearly documented.

Evidence

“The national research ethics committee approved this study on 26 July 2018 (18/WA/0236), with each trial site granting individual NHS Trust approval before recruitment at each site.”

MethodsFind in source

“After assessment, potential participants were provided with verbal and written information before they provided written informed consent.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The national research ethics committee approved this study on 26 July 2018 (18/WA/0236)”

MethodsFind in source

“After assessment, potential participants were provided with verbal and written information before they provided written informed consent.”

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 interventions are described in sufficient detail, and the statistical software is identified.

Evidence

“Analyses were conducted in R (version 4.0.3)”

Statistical analysisFind in source

“Each additional session lasted for up to 30 min, over a maximum duration of four months from the date of randomisation.”

MethodsFind in source

PASSReviewer 2· 85% conf

The investigational interventions are adequately described, and statistical software is identified.

Evidence

“All participants had an initial period in which the injured arm was supported in a sling and then received an appointment for a physiotherapy advice session within six weeks of their injury.”

MethodsFind in source

“Analyses were conducted in R (version 4.0.3)”

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 appropriate and well-reported, with exact p-values and confidence intervals for effect sizes.

Evidence

“Unadjusted and adjusted mixed effects linear regression models were used to estimate the between group difference.”

Statistical analysisFind in source

“6 months | 180 | 36.2 (10.7) | 174 | 38.4 (9.2) | 1.5 (−0.3 to 3.5) | 0.11”

Table 2Find in source

“between group difference favouring physiotherapy 1.5 (95% confidence interval −0.3 to 3.5)”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well reported, with exact p-values and confidence intervals.

Evidence

“Unadjusted and adjusted mixed effects linear regression models were used to estimate the between group difference.”

Statistical analysisFind in source

“0.7 (−1.0 to 2.4) | 0.44”

Table 2Find in source

“between group difference favouring physiotherapy 1.5 (95% confidence interval −0.3 to 3.5)”

AbstractFind 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 clear mechanism or timeframe for access.

Evidence

“All data requests should be submitted to WCTUDataAccess@warwick.ac.uk for consideration. Access to anonymised data may be granted following review.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement is present but vague, lacking a clear mechanism or timeframe.

Evidence

“All data requests should be submitted to WCTUDataAccess@warwick.ac.uk for consideration. Access to anonymised data may be granted following review.”

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· 95% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“Trial registration Current Controlled Trials ISRCTN63184243.”

AbstractFind in source

“The main limitation was the 27% loss to follow up, however, the observed standard deviation was much smaller than anticipated.”

LimitationsFind in source

“Funding: This trial was funded by the National Institute for Health and Care Research (16/167/56), 01/06/18.”

FundingFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“Trial registration Current Controlled Trials ISRCTN63184243.”

AbstractFind in source

“The main limitation was the 27% loss to follow up”

LimitationsFind in source

“This trial was funded by the National Institute for Health and Care Research (16/167/56), 01/06/18.”

FundingFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

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 15 references by DOI: 15 verified.

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.
HIGHdata code
In the Data availability statement, specify the conditions and timeframe for data access, e.g., 'Requests will be reviewed within 30 days and data will be shared after approval and a data sharing agreement.'
The current statement is vague and does not meet common transparency expectations for a data-driven trial.
2.
HIGHreporting
In the Methods or Acknowledgments, explicitly state adherence to the CONSORT reporting guideline.
The paper follows CONSORT-like structure but does not explicitly confirm adherence, which is a standard expectation for RCTs.
3.
MEDIUMreporting
In the Methods, add a link to the statistical analysis plan (Supplement 1) for transparency.
Providing a direct link improves reproducibility and reviewer confidence.
4.
MEDIUMreporting
In the Methods, clarify the role of the data monitoring committee and trial steering committee.
Enhances governance transparency for a multicentre trial.
5.
MEDIUMcopyedit
In Table 3, correct the EQ-5D-5L confidence interval from '0.009 (−0.26 to 0.047)' to '0.009 (−0.026 to 0.047)'.
The current CI has inconsistent decimal places and appears to be a typographical error.
6.
MEDIUMcopyedit
In the Acknowledgments, correct the misspelled names 'Fracnesca Gowing' to 'Francesca Gowing' and 'Lynn Osbome' to 'Lynn Osborne'.
Misspelling collaborator names is unprofessional and should be fixed.
7.
LOWcopyedit
In Results, Participants and adherence, change '81% (n=194) of 240 participants receiving advice only' to '81% (n=194) of 240 participants received advice only'.
Verb tense inconsistency reduces readability.
8.
LOWcopyedit
In Discussion, Principal findings, change 'We did not report a difference' to 'We did not find a difference'.
Awkward phrasing; 'find' is more natural.
9.
LOWcopyedit
In Discussion, Comparison with other studies, consider splitting the long sentence about the supervised physiotherapy group for clarity.
Long sentences reduce readability.
10.
LOWdata code
Consider depositing the statistical analysis plan and any non-identifiable aggregate data in a public repository (e.g., Zenodo) with a DOI.
Would further improve transparency and reproducibility.
11.
LOWdata code
Include a statement on the availability of the statistical analysis code, even if on request.
Clarifies code availability and supports reproducibility.

Full text (60,899 chars)Analyzed: Aug 16, 2026