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Kaimen Rigor review

Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK).

Azuara-Blanco A, Logan NS, McConnell E, Kearney S, Kirk G, Jones S, McDowell C, Murphy L, O'Hanlon G, McFarland M, Painter S, Muthusamy B, Nabili S, Preston J, Flitcroft I, Loughman J, Mackey D, Lee S, Dahlmann-Noor A, Congdon N, Hogg RE, Hammond CJ, Saunders K, Allen PM, Strang N, Clarke M

DOI: 10.1136/bmj-2025-086698
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-22

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/7fc84898-673b-47f5-abfb-4c9405fb38f3 is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ReportingData & code availability not met−0.5★

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

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 12 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.

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
The data availability statement is incomplete and does not provide a concrete access route, and no code repository is mentioned. This is a significant reporting gap.
“Data availability statement The code used to analyse the data in the paper ca”
End of manuscriptFind in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions · partly checked 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.

The paper reports a well-designed and well-conducted clinical trial with strong methodological rigor across most dimensions. The primary weakness is the incomplete data availability statement and absence of a code repository, which is a critical reporting gap. Minor copyedit issues (Table 1 typo, white-ethnicity count discrepancy, mixing analysis populations in the Discussion) also warrant correction.

Both independent reviewers were in agreement on seven dimensions; they diverged on data code availability (warn vs. fail), with the synthesis adopting fail based on the incomplete statement and missing code. The statistics verification covered 11 recomputable tests (all consistent) but does not verify all unreported calculations. The citation check found no retracted or non-existent references. No reproducibility assessment was run.

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 11 tests: 11 consistent, 0 inconsistent; 11 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Primary outcome, intention-to-treat, fully adjusted: mean difference 0.33 D (95% CI 0.17 to 0.49), P<0.001
“0.33 (0.17 to 0.49) | <0.001”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around the point estimate 0.33; the estimate is on the natural difference scale, not a log ratio; the CI was computed from the same GEE model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation (z = |estimate|/(width/(2*1.96))).
How we recomputed it: pCI(0.33, 0.17, 0.49, 0)
CONSISTENTreported p = .530 · recomputed p = .537Reviewer 1
Reading speed, intention-to-treat (ANCOVA): mean difference -1.70 (95% CI -7.10 to 3.69), P=0.53
“-1.70 (-7.10 to 3.69) | 0.53”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around -1.70; the estimate is on the natural difference scale; the CI is from the ANCOVA model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-1.70, -7.10, 3.69, 0)
CONSISTENTreported p = .870 · recomputed p = .868Reviewer 1
Uniocular best corrected distance visual acuity, intention-to-treat (GEE): mean difference -0.08 (95% CI -1.02 to 0.87), P=0.87
“-0.08 (-1.02 to 0.87) | 0.87”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around -0.08; the estimate is on the natural difference scale; the CI is from the GEE model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-0.08, -1.02, 0.87, 0)
CONSISTENTreported p = .097 · recomputed p = .095Reviewer 1
Binocular best corrected distance visual acuity, intention-to-treat (ANCOVA): mean difference 0.60 (95% CI -0.11 to 1.30), P=0.097
“0.60 (-0.11 to 1.30) | 0.097”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around 0.60; the estimate is on the natural difference scale; the CI is from the ANCOVA model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(0.60, -0.11, 1.30, 0)
CONSISTENTreported p = .003 · recomputed p = .003Reviewer 1
Central axial length, intention-to-treat (GEE, adjusted for baseline): mean difference -0.12 (95% CI -0.20 to -0.04), P=0.003
“-0.12 (-0.20 to -0.04) | 0.003”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around -0.12; the estimate is on the natural difference scale; the CI is from the GEE model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-0.12, -0.20, -0.04, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Pupil diameter, intention-to-treat (GEE): mean difference 0.36 (95% CI 0.17 to 0.55), P<0.001
“0.36 (0.17 to 0.55) | <0.001”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around 0.36; the estimate is on the natural difference scale; the CI is from the GEE model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(0.36, 0.17, 0.55, 0)
CONSISTENTreported p = .030 · recomputed p = .039Reviewer 1
Amplitude of accommodation, intention-to-treat (GEE): mean difference -1.0 (95% CI -2.0 to -0.1), P=0.03
“-1.0 (-2.0 to -0.1) | 0.03”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around -1.0; the estimate is on the natural difference scale; the CI is from the GEE model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-1.0, -2.0, -0.1, 0)
CONSISTENTreported p = .180 · recomputed p = .183Reviewer 1
EQ-5D-Y visual analogue scale, intention-to-treat (ANCOVA): mean difference -1.62 (95% CI -4.01 to 0.76), P=0.18
“-1.62 (-4.01 to 0.76) | 0.18”
Find in source
Taken as given: the 95% CI is two-sided and symmetric (Wald-type) around -1.62; the estimate is on the natural difference scale; the CI is from the ANCOVA model that produced the p-value
Method: Two-tailed p from estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-1.62, -4.01, 0.76, 0)
CONSISTENTreported p = .003 · recomputed p = .001Reviewer 1
Post hoc categorical analysis: stable myopia (<0.25 D progression), atropine 61/151 vs placebo 15/79, P=0.003 (chi-square)
“more participants had stable myopia (a change in level of myopia less than 0.25 D) in the atropine group (n=61, 40%) than in the control group (n=15, 19%, P=0.003)”
Find in source
Taken as given: 61 and 15 are the event counts (stable myopia) in the atropine (n=151) and placebo (n=79) arms; the non-event counts are 90 (151-61) and 64 (79-15); the test is Pearson's chi-square as stated ('P values from χ 2 test')
Method: Two-tailed Pearson chi-square on the 2x2 table from cell counts.
How we recomputed it: pChi2x2(61, 90, 15, 64)
CONSISTENTreported p = .007 · recomputed p = .003Reviewer 1
Post hoc categorical analysis: significant progression (>0.50 D), atropine 64/151 vs placebo 50/79, P=0.007 (chi-square)
“fewer participants with significant myopia progression (change more than 0.50 D) in the atropine group (n=64, 42%) than in the control group (n=50, 63%, P=0.007)”
Find in source
Taken as given: 64 and 50 are the event counts (progression >0.50 D) in the atropine (n=151) and placebo (n=79) arms; the non-event counts are 87 (151-64) and 29 (79-50); the test is Pearson's chi-square as stated ('P values from χ 2 test')
Method: Two-tailed Pearson chi-square on the 2x2 table from cell counts.
How we recomputed it: pChi2x2(64, 87, 50, 29)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Primary outcome: adjusted mean difference in spherical equivalent refractive error at 24 months (ITT).
“mean difference 0.33 D, 95% CI 0.17 to 0.49, P<0.001”
Find in source
Taken as given: The estimate is the adjusted mean difference from the ITT analysis.; The 95% confidence interval is two-sided and based on a normal approximation.; The test is two-sided.
Method: p-value derived from the estimate and its 95% confidence interval using the pCI function, which assumes a normal distribution of the estimate.
How we recomputed it: pCI(0.33, 0.17, 0.49, 0)

lowinternal contradiction
The Discussion sentence 'Changes in refractive error and central axial length... were reduced... by a mean of 0.38 D and 0.14 mm' mixes analysis populations: 0.38 D is the per-protocol refractive-error estimate (Table 2 PP: 0.38, 0.20 to 0.56) while 0.14 mm is the intention-to-treat axial-length estimate (Table 2 ITT: -0.14, -0.21 to -0.07).
“Changes in refractive error and central axial length, both key quantifiers of myopia, were reduced with the atropine compared with placebo eye drops by a mean of 0.38 D and 0.14 mm, respectively.”
DiscussionFind in source
lowinternal contradiction
The white-ethnicity count differs between the Table 1 minimisation-factor row (138 atropine / 209 total) and the detailed ethnicity row plus the abstract (136 atropine / 207 total). Both rows sum internally (136+13+26+2+8+7=192; 71+6+9+1+3+7=97), so one of the counts is in error by 2 participants.
White | 138 (72) | 71 (73) | 209 (72) ... White | 136 (701) | 71 (73) | 207 (72) ... 207 (72%) reported white ethnicity
Table 1reviewer’s wording
lowinternal contradiction
The results text reports '16 (16%) v 24 (42%)' for progression of 1 D or more; these are the per-protocol percentages from Table 3 (PP >1 D row) but are presented without a per-protocol label amid intention-to-treat results, so a reader could misattribute them to the ITT population.
“The number of children with progression of 1 D was substantially reduced in the atropine versus control group (16 (16%) v 24 (42%))”
ResultsFind in source

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

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

partialReviewer 2
The effect size is similar to other trials conducted primarily on Chinese populations.
The paper compares the effect size to the Cochrane review and other studies, but notes that the effect size is similar to that in Chinese populations, which is supported by the comparison table and discussion.
Evidence: Discussion: 'The effect size in refractive error observed in our study is similar to other trials conducted primarily on Chinese populations evaluating low concentrations of atropine.'
“The effect size in refractive error observed in our study is similar to other trials conducted primarily on Chinese populations evaluating low concentrations of atropine.”
DiscussionFind in source
supportedReviewers 1, 2
Low concentration atropine (0.01%) eye drops significantly reduced progression of myopia and were well tolerated compared with placebo in children in the UK.
The primary outcome (mean difference 0.33 D, 95% CI 0.17 to 0.49, P<0.001) and the tolerability/adverse-event results directly support both efficacy and tolerability.
Evidence: Abstract conclusion; Table 2 primary outcome MD 0.33 D (0.17 to 0.49) P<0.001; 'no differences in frequency of adverse events or in tolerability measures'.
“Low concentration atropine (0.01%) eye drops significantly reduced progression of myopia and were well tolerated compared with placebo in children in the UK.”
ConclusionFind in source
supportedReviewer 1
Atropine eye drops were more effective than placebo in reducing myopia progression (mean difference 0.33 D, 95% CI 0.17 to 0.49 D, P<0.001).
The primary outcome analysis in Table 2 exactly matches this claim for both ITT (0.33) and PP (0.38) analyses.
Evidence: Table 2 ITT fully adjusted mean difference 0.33 (0.17 to 0.49), P<0.001.
“Atropine eye drops were more effective than placebo in reducing myopia progression (mean difference 0.33 D, 95% confidence interval (CI) 0.17 to 0.49 D, P<0.001).”
AbstractFind in source
supportedReviewer 1
Changes in central axial length were significantly less in the atropine group versus placebo group (mean difference 0.14 mm, 95% CI 0.07 to 0.21, P<0.001).
Table 2 ITT fully adjusted axial-length difference -0.14 (-0.21 to -0.07), P<0.001 matches the claim.
Evidence: Table 2 central axial length ITT fully adjusted MD -0.14 (-0.21 to -0.07), P<0.001.
“Changes in central axial length were significantly less in the atropine group versus placebo group: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001).”
AbstractFind in source
supportedReviewers 1, 2
Prespecified subgroup analyses did not show differences according to age, ethnicity, sex, or severity of myopia.
Table 5 shows no statistically significant interaction terms for any subgroup; the paper itself cautions the study was underpowered for subgroups, which tempers but does not contradict the claim.
Evidence: Table 5 subgroup analyses with interaction P values (e.g., age 0.07, ethnicity 0.80, sex 0.29).
“Prespecified subgroup analyses did not show differences according to age, ethnicity, sex, or severity of myopia.”
AbstractFind in source
supportedReviewer 1
Low concentration 0.01% atropine treatment was well tolerated and effective and should be considered as an alternative to manage myopia progression.
Efficacy and tolerability are demonstrated by the trial data; the 'should be considered as an alternative' recommendation is a clinical judgment grounded in, and not exceeding, that evidence, with the paper appropriately noting the effect was small.
Evidence: Primary and secondary outcomes, adverse-event equivalence, and the Discussion's measured framing of the modest effect.
“Low concentration 0.01% atropine treatment was well tolerated and effective and should be considered as an alternative to manage myopia progression.”
ConclusionFind in source
supportedReviewer 2
Atropine was well tolerated.
No significant differences in adverse events or tolerability measures between groups, and no serious adverse events related to treatment.
Evidence: Table 2 and text: 'There were no differences in frequency of adverse events or in tolerability measures.'
There were no differences in other secondary outcomes, except pupil diameter... and no differences in frequency of adverse events or in tolerability measures.
Abstractreviewer’s wording
supportedReviewer 2
Changes in central axial length were significantly less in the atropine group.
The secondary outcome shows a significant mean difference of 0.14 mm (95% CI 0.07 to 0.21, P<0.001).
Evidence: Secondary outcome: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001)
“Changes in central axial length were significantly less in the atropine group versus placebo group: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001).”
AbstractFind in source

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 high

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 and code not sharedAssessed

Eight Dimensions7 pass · 1 fail

The introduction cites the rising prevalence of myopia, the Cochrane review on atropine, and uncertainties about effectiveness in European populations. The rationale for the trial is logically derived from these gaps. The discussion explicitly addresses limitations of previous studies, such as small sample sizes and lack of objective adherence measures.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The premise is well established: rising myopia prevalence, the proven but side-effect-limited efficacy of high-dose atropine, and the uncertainty about low-concentration atropine in European-derived populations are all documented, and the rationale flows directly into the trial objectives.

Evidence

“A recent Cochrane review found that high concentration atropine (≥0.5%) may be the most effective treatment option, but the side effects (photophobia, blurred vision at near reading distance, and allergic reactions) render it unsuitable for routine clinical interventions”

IntroductionFind in source

“Although most trials using atropine for myopia control have been conducted in children of Chinese ethnicity, several recent studies have examined low concentration atropine in western populations, with variable results.”

IntroductionFind in source

“Limitations of previously published studies include smaller sample sizes and a lack of an objective measure of eye drop use, with typically calendar review and parental report used to record adherence to eye drop use.”

DiscussionFind in source

PASSReviewer 2· 100% conf

The scientific premise is well established through extensive citation of prior research, a clear rationale linking the evidence to the study objectives, and acknowledgment of limitations in prior work.

Evidence

paraphrase[Introduction, paragraph 4]

“A recent Cochrane review found that high concentration atropine (≥0.5%) may be the most effective treatment option, but the side effects... render it unsuitable.”

paraphrase[Introduction, final paragraph]

“In the CHAMP-UK study we evaluated the efficacy, safety, and mechanism of action of low concentration atropine (0.01%) in UK children with myopia aged 6 to 12 years.”

paraphrase[Discussion, 'Strengths and limitations of this study']

“Limitations of previously published studies include smaller sample sizes and a lack of an objective measure of eye drop use.”

Randomization was computer-generated using minimisation, with allocation concealment. Blinding of participants, investigators, and monitors was maintained. A detailed sample size calculation was provided. Inclusion and exclusion criteria were pre-specified. The primary analysis followed intention-to-treat, and missing data were handled with sensitivity analyses.

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: computer-generated minimisation randomisation with concealment, participant-level randomisation, full masking of investigators and participants, a pre-specified power calculation, explicit eligibility criteria, and a defined ITT/complete-case analysis with missing-data sensitivity analyses.

Evidence

“Randomisation (2:1) was computer generated using a minimisation algorithm to ensure balanced allocation of participants across the two treatment groups.”

MethodsFind in source

“The unit of randomisation was the participant (not the eye).”

MethodsFind in source

“Investigators (chief, principal, and co-investigators), study monitors, and study participants were all masked throughout the study.”

MethodsFind in source

paraphrase[Methods, Sample size]

“we determined that we would need 228 participants (456 eyes)... to detect this difference in the non-Chinese UK population with 90% power.”

PASSReviewer 2· 100% conf

The study design is rigorous, with clear randomization, blinding, power analysis, and inclusion/exclusion criteria. All applicable sub-criteria for a human RCT are adequately reported.

Evidence

“Randomisation (2:1) was computer generated using a minimisation algorithm to ensure balanced allocation of participants across the two treatment groups.”

MethodsFind in source

“Investigators (chief, principal, and co-investigators), study monitors, and study participants were all masked throughout the study.”

MethodsFind in source

paraphrase[Methods, 'Sample size']

“We determined that we would need 228 participants (456 eyes). Considering a dropout rate of 15%... we increased the number required to a total of 289 participants.”

Table 1 provides detailed baseline characteristics for both groups, including sex, age, weight, height, ethnicity, and ocular measures. Both sexes are enrolled, so sex justification is not applicable. Demographics are fully reported.

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

Sex, age, weight, height, ethnicity, and parental myopia are all reported in Table 1; both sexes were enrolled so no single-sex justification is required.

Evidence

“161 (56%) were girls”

AbstractFind in source

“Mean (SD) age (years) | 9.3 (1.7) | 9.3 (1.7) | 9.3 (1.7)”

Table 1Find in source

“207 (72%) reported white ethnicity”

AbstractFind in source

PASSReviewer 2· 100% conf

Biological variables and participant characteristics are comprehensively reported, including sex, age, weight, height, ethnicity, and health status.

Evidence

paraphrase[Table 1]

“Girl 102 (53) 59 (61) 161 (56)”

paraphrase[Table 1]

“Mean (SD) age (years) 9.3 (1.7) 9.3 (1.7) 9.3 (1.7)”

paraphrase[Table 1]

“White 136 (701) 71 (73) 207 (72)”

The study was approved by the Office for Research Ethics Committees Northern Ireland (reference 18/NI/0164). Parental consent was obtained before enrollment. Compliance with Good Clinical Practice and the European Clinical Trials Directive is mentioned.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial was reviewed and approved by a named research ethics committee with a protocol reference, parental consent is described, and GCP/European Clinical Trials Directive compliance is stated.

Evidence

“CHAMP-UK (Childhood Atropine for Myopia Progression in the UK) was reviewed and approved by the Office for Research Ethics Committees Northern Ireland (reference 18/NI/0164).”

EthicsFind in source

“After parental consent had been obtained, children were screened and, if eligible, enrolled and randomised.”

MethodsFind in source

“Serious adverse events related to the use of the study drugs in the trial were reported in accordance with the guidance from the European Clinical Trials Directive 2001/20/EC”

MethodsFind in source

PASSReviewer 2· 100% conf

Ethical approvals and consent are clearly documented: a named ethics committee approved the study, parental consent was obtained, and regulatory compliance is stated.

Evidence

paraphrase[Ethics statements]

“CHAMP-UK was reviewed and approved by the Office for Research Ethics Committees Northern Ireland (reference 18/NI/0164).”

“After parental consent had been obtained, children were screened and, if eligible, enrolled and randomised.”

MethodsFind in source

paraphrase[Methods, 'Adverse events and safety reporting']

“Serious adverse events related to the use of the study drugs in the trial were reported in accordance with the guidance from the European Clinical Trials Directive 2001/20/EC.”

The study drug is named with source (Stockport Pharmaceuticals) and formulation details. Statistical software Stata 15.1 is identified. Antibodies, cell lines, and organisms are not used.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (atropine sulfate 0.01%) and placebo are identified with formulation, preservative, dose, regimen, and manufacturer; analysis software is named with version.

Evidence

“The intervention group was assigned to receive preserved atropine sulfate 0.01% eye drops once daily at bedtime in both eyes for two years.”

MethodsFind in source

“The study drug was developed and supplied by Stockport Pharmaceuticals”

MethodsFind in source

“Analyses were performed with Stata Statistical Software, version 15.1 (StataCorp, College Station, TX).”

Statistical analysisFind in source

PASSReviewer 2· 100% conf

The investigational product (atropine 0.01%) and statistical software are adequately identified. No other biological resources are applicable.

Evidence

paraphrase[Discussion, 'Strengths and limitations']

“The study drug was developed and supplied by Stockport Pharmaceuticals.”

“Analyses were performed with Stata Statistical Software, version 15.1 (StataCorp, College Station, TX).”

Statistical analysisFind in source

The analysis uses GEE, ANCOVA, t-tests, and χ² tests. Effect sizes are presented with 95% CIs. Data are shown with means, SDs, and Ns. The primary outcome p-value is reported as <0.001, which is a threshold, but the CI is provided. No arithmetic errors were detected.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Statistical methods are named (GEE, ANCOVA, t-test, chi-square, mixed models), effect estimates are reported with 95% CIs and p-values, software is identified, and the clinical reporting idiom is followed. Minor p-value/CI rounding and a Table 1 count discrepancy do not constitute a demonstrable arithmetic error.

Evidence

“We compared the atropine and control groups using generalised estimating equations and 95% confidence intervals (CIs) to allow for the correlation between eyes within a participant.”

Statistical analysisFind in source

“0.33 (0.17 to 0.49) | <0.001”

Table 2Find in source

paraphrase[Results]

“atropine 0.01% eye drops reduced myopia progression compared with placebo... (mean difference 0.33 D, 95% CI 0.17 to 0.49, P<0.001)”

PASSReviewer 2· 95% conf

Statistical methods are appropriate and well-reported, with named tests, effect sizes with CIs, and data presentation. The primary p-value is reported as a threshold, but this is standard for clinical trials and does not undermine the overall assessment.

Evidence

“mean difference 0.33 D, 95% CI 0.17 to 0.49, P<0.001”

Results ¶2Find in source

paraphrase[Table 2]

“Mean difference (95% CI) 0.33 (0.17 to 0.49)”

“Analyses were performed with Stata Statistical Software, version 15.1”

Statistical analysisFind in source

The data availability statement is cut off and appears to be incomplete. It mentions 'The code used to analyse the data in the paper ca' without specifying a repository or access mechanism. No code sharing is provided. For a clinical trial, a data access statement is required.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 60% conf

A data availability statement exists and indicates that analysis code is shared, but the provided text is truncated mid-sentence, so the concrete access route (repository or managed-access mechanism) cannot be verified.

Evidence

“Data availability statement The code used to analyse the data in the paper ca”

Data availabilityFind in source

FAILReviewer 2· 70% conf

The data availability statement is incomplete and does not provide a concrete access route, and no code repository is mentioned. This is a significant reporting gap.

Evidence

“Data availability statement The code used to analyse the data in the paper ca”

End of manuscriptFind in source

absence[End of manuscript]

No code repository is mentioned.

The methods are comprehensive and reproducible. The trial is registered (ISRCTN99883695, NCT03690089). All pre-specified outcomes are reported, including negative results. Limitations are explicitly discussed. Conclusions are proportional to the evidence. Funding and conflicts are declared. No reporting guideline is referenced.

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· 85% conf

Reporting is thorough: methods are complete, the trial is registered (ISRCTN and ClinicalTrials.gov), all pre-specified outcomes including null results are reported, limitations are discussed, conclusions are measured, and funding/COI are disclosed. The only gap is the absence of an explicit CONSORT statement.

Evidence

“Trial registration ISRCTN registry ISRCTN99883695, ClinicalTrials.gov NCT03690089”

AbstractFind in source

“Funding: National Institute for Health and Care Research Efficacy and Mechanism Evaluation (project 15/48/59).”

FundingFind in source

“In addition, subgroup analyses were underpowered to be able to detect differences; tolerability was not assessed with a validated questionnaire; the covid-19 pandemic occurred during the current study timeline”

LimitationsFind in source

PASSReviewer 2· 100% conf

The manuscript is transparent and complete, with detailed methods, trial registration, all outcomes reported, limitations discussed, and proportional conclusions. The only missing element is a reference to a reporting guideline.

Evidence

“Trial registration ISRCTN registry ISRCTN99883695, ClinicalTrials.gov NCT03690089”

AbstractFind in source

paraphrase[Discussion, 'Strengths and limitations of this study']

“A limitation of the current study is that as it is an efficacy trial, with adherence assessed by MEMS device, the generalisability of these findings to non-trial settings is unknown.”

“Funding: National Institute for Health and Care Research Efficacy and Mechanism Evaluation (project 15/48/59).”

FundingFind in source

Registered (2 IDs: ClinicalTrials.gov, ISRCTN). No reporting guideline cited.

ClinicalTrials.gov

NCT03690089

ISRCTN

ISRCTN99883695

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 51 references by DOI: 47 verified — 4 no DOI (shown, not verified).

NO DOI
SPECS 2030
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Atropine reduces experimental myopia and eye enlargement via a nonaccommodative mechanism
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The Hong Kong progressive lens myopia control study: study design and main findings
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Priority 10 Sight Loss and Vision PSP Refractive Error and Motility. Can we precent myopia?
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

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 consistency, typo, clarity.

MINORtypoTable 1, Ethnicity row
“136 (701)”
→ 136 (71)
The percentage '701' is impossible; should be '71' (136/192 = 70.8%).
MINORconsistencyTable 1 vs Abstract
“White | 138 (72) | 71 (73) | 209 (72) ... White | 136 (701) | 71 (73) | 207 (72)”
→ Make the white-ethnicity count identical across the minimisation-factor row, the detailed ethnicity row, and the abstract (207 vs 209).
The minimisation-factor row total for white is 209 while the ethnicity row and abstract give 207.
MINORconsistencyResults, post hoc sensitivity analysis
“16 (16%) v 24 (42%)”
→ Label as per-protocol analysis: '16 (16%) v 24 (42%) in the per protocol analysis'.
These figures are the per-protocol progression >1 D values from Table 3 but are presented without the analysis-population label amid intention-to-treat results.
MINORtypoTable 1, 'White' row under 0.01% atropine sulfate
“136 (701)”
→ 136 (71)
The percentage appears to be 71% but is written as '701', likely a typographical error.
MINORconsistencyTable 1, 'Mean (SD) monocular BCdVA (logMAR)'
“84.0 (3.7)”
→ Check if these values are correctly scaled (logMAR typically 0.0-1.0, but here they appear to be Snellen-like scores).
The values reported (e.g., 84.0) are unusually high for logMAR visual acuity; they may represent a different scale (e.g., ETDRS letters). Clarification would improve transparency.
MINORclarityData availability statement
“The code used to analyse the data in the paper ca”
→ Complete the sentence and specify the repository or access mechanism.
The statement is cut off; it should be completed to indicate where the code can be accessed.

Kaimen Rigor Action ItemsFinal pass before journal submission

This published paper is methodologically robust, but the incomplete data availability statement (truncated, no code repository) is a significant reporting deficiency that would warrant an erratum or correction. An informed reader should note that the analysis code is not verifiably shared, and the Table 1 inconsistency and mixing of analysis populations in the Discussion reduce confidence in some reported figures. The study's primary conclusions are supported by the available evidence, but an independent re-analysis would be needed to confirm the results without access to the code.

1.
HIGHdata code
Complete the data availability statement (currently truncated at 'The code used to analyse the data in the paper ca...') to specify the repository or managed-access mechanism for the analysis code and de-identified participant-level data.
Without a complete statement, readers cannot verify the analysis or access the data, which undermines reproducibility.
2.
HIGHdata code
Deposit the analysis code in a permanent repository (e.g., GitHub, Zenodo) and update the data availability statement with the DOI or link.
The current statement mentions code but provides no access route; a repository deposit is required for verification.
3.
HIGHreporting
Reconcile the white-ethnicity count discrepancy between Table 1's minimisation-factor row (138 atropine, 209 total) and the detailed ethnicity row plus abstract (136 atropine, 207 total); correct the error so all rows agree.
Internal inconsistency in baseline characteristics undermines trust in the data quality.
4.
HIGHreporting
In the Results section where '16 (16%) v 24 (42%)' is reported for progression >1 D, label these figures as per-protocol analysis (from Table 3) to avoid misattribution to the intention-to-treat population.
Presenting per-protocol values without a label amid ITT results can mislead readers about the analysis population.
5.
HIGHreporting
In the Discussion sentence that cites '0.38 D' and '0.14 mm', clarify that the refractive-error effect is the per-protocol estimate and the axial-length effect is the intention-to-treat estimate, to avoid mixing analysis populations.
Mixing analysis populations in a single sentence confuses the interpretation of the reported effects.
6.
MEDIUMcopyedit
Fix the typo in Table 1's ethnicity row: change '136 (701)' to '136 (71)'.
The percentage '701' is impossible and should be '71' based on the count (136/192 = 70.8%).
7.
MEDIUMcopyedit
Clarify the scale of the visual acuity measures in Table 1 (e.g., '84.0 (3.7)') — if these are ETDRS letters rather than logMAR, state this explicitly.
The values reported for monocular BCdVA are unusually high for logMAR and may mislead readers if the scale is not stated.
8.
MEDIUMreporting
Explicitly reference adherence to the CONSORT reporting guideline in the Methods or a reporting section, even though a CONSORT-style flow diagram is present.
Acknowledging CONSORT compliance is expected for clinical trial reports and is currently missing.

Full text (58,189 chars)Analyzed: Aug 10, 2026

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK).

DOI

10.1136/bmj-2025-086698

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-22