Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

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

Recomputed 4 tests: 4 consistent, 0 inconsistent, 4 via agent-written checks.

2 integrity concerns flagged (0 high).

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

Checked 40 references: 39 verified — 1 unresolved.

1 data/code link checked; 1 live.

Ready after minor edits. The most critical issues are (1) verifying the unresolved reference, (2) tempering the claim that the lack of power did not affect results, and (3) addressing the sample size limitation. The copyedit items are minor and should be fixed before submission.

1. 1.
   HIGHethics

   Verify the reference titled 'Interventions for treating scabies' that was not found in any registry; if it is a genuine reference, correct the citation details, or if it is erroneous, remove or replace it. This is a fabrication signal.

   A citation not found in any registry may indicate a missing or fabricated reference, which could undermine the paper's credibility.
2. 2.
   HIGHrigor

   In the Discussion, either provide evidence supporting the claim that 'the theoretical lack of power not affecting the final results' or temper the statement. The sample size shortfall (294 vs 502 clusters) is substantial and requires justification.

   The integrity review flagged this as an internal contradiction; a strong claim without justification may be challenged by reviewers.
3. 3.
   HIGHother

   In the Methods (Sample size), explicitly discuss the implications of not accounting for clustering in the sample size calculation and consider adding a sensitivity analysis or a post-hoc power estimation that accounts for the intracluster correlation coefficient (ICC).

   The sample size calculation is a key design element; ignoring clustering reduces power and the authors should address this limitation transparently.
4. 4.
   HIGHstatistics

   In the Statistical methods section, add a statement verifying that the assumptions of the mixed models (e.g., normality of residuals, homoscedasticity) were checked and satisfied, or cite the robustness of the method.

   Two reviewers noted that model assumptions are not discussed; this is a standard reporting requirement for mixed models.
5. 5.
   HIGHreporting

   In the Methods (Sample size), clarify the contradictory sentence: 'Therefore, sample size calculation was standard (ie, without considering any clustering)' – explain why the sample size calculation was standard despite the cluster design, and note that this may have reduced power.

   The copyedit pass flagged this as unclear; it could confuse readers about the design's validity.
6. 6.
   MEDIUMrigor

   In the Methods (Statistical analysis), provide more detail on the multiple imputation model: specify the covariates included, the number of imputations, and how the imputation model handled clustering.

   A reviewer requested this to enhance reproducibility; it is a standard requirement for reporting imputation.
7. 7.
   MEDIUMreporting

   In the Methods (Outcomes), clarify the definition of 'post-scabietic pruritus' and how it was adjudicated by the two masked investigators, including the criteria used.

   A reviewer noted that the definition affects the primary outcome and should be explicit.
8. 8.
   MEDIUMstatistics

   Report exact p-values alongside confidence intervals for the primary and key secondary analyses, particularly for the non-inferiority test, to facilitate future meta-analyses.

   Two reviewers suggested this; while CIs are adequate, exact p-values are helpful for secondary analyses.
9. 9.
   MEDIUMethics

   Add an explicit statement in the Ethics section that the trial was conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines.

   One reviewer flagged this as missing; while the approvals imply compliance, an explicit statement is standard for clinical trial reports.
10. 10.
    MEDIUMreporting

    In the Results, consider adding a table summarizing the demographic and clinical characteristics of participants who dropped out to assess potential attrition bias.

    One reviewer suggested this to improve transparency about loss to follow-up.
11. 11.
    MEDIUMrigor

    In the Methods, describe the rules for handling outliers or protocol deviations (e.g., children <15 kg who received permethrin per protocol) beyond the imputation approach.

    Two reviewers noted that outlier handling is not explicitly addressed; this is a standard reporting item.
12. 12.
    LOWcopyedit

    Abstract: Add a colon after 'Participants' heading (i.e., 'Participants: Index cases...').

    Minor typo identified by the copyedit pass.
13. 13.
    LOWcopyedit

    Results, first paragraph: Rephrase 'without access to the data' to clarify that the decision was made without unblinded interim data analysis, not that the committee was blind to the trial.

    Copyedit pass flagged this as potentially ambiguous.
14. 14.
    LOWcopyedit

    Methods, Intervention: Replace 'posology' with 'dosage' for clarity.

    Copyedit pass noted that 'posology' is less common; 'dosage' is standard.
15. 15.
    LOWreporting

    Consider adding a dot plot of cluster-level cure rates as a supplementary figure to show individual variability.

    One reviewer suggested this to improve data presentation.