Rigor Reviewed

Rigor-Reviewed Manuscript

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

Name: Adcurare Rigor Record — Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.
Item: Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.
Rating: 100
Author: Adcurare

Boralevi F, Simon G, Bernigaud C, Brun J, Goujon E, Perrot JL, Phan A, Hérissé AL, Maruani A, Vanhaecke C, Couty E, Abasq-Thomas C, Fournet M, Mallet S, Brenaut E, Hubiche T, Balguerie X, Caux F, Beneton N, Dutkiewicz AS, Adamski H, Aubert H, Bourrat E, Couzan C, Eyraud A, Janela-Lapert R, Marti A, Miquel J, Richard M, Barbarot S, Bonniaud B, Chabbert C, Delion F, Dinulescu M, Duong TA, Etienne M, Hirsch G, Isnard C, Huet F, Le Bidre E, Leducq S, Legrand A, Monestier S, Morice-Picard F, Seneschal J, Capelli A, Lacoste C, Labrèze C, Miraglia G, Do-Pham G, Giraudeau B, Chosidow O

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Adcurare Rigor Review — 3.75★ (Adequate), 0 critical, 5 high issues for “Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

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★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.6.0Source: full text

Problems surfaced3 types

Internal contradictions in the reported numbers
Data look implausibly clean
References not resolvable to a published paper

This Adcurare Rigor Review uses AI 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 presents a well-conducted cluster-randomised trial with strong transparency, including open data and code, preregistration, and adherence to CONSORT. Minor methodological gaps include a sample size calculation that did not account for clustering and a lack of formal verification of mixed model assumptions. The manuscript is nearly ready for submission, with only a few reporting and clarity improvements needed.

Three independent rigor evaluations were synthesized. The study is a cluster-randomised clinical trial; many sub-criteria (e.g., species/strain, IACUC) were not applicable. Reviewers diverged on power analysis (one rated inadequate) and ethical approvals (one rated warn due to missing explicit regulatory framework statement); our synthesis resolves both to pass with minor caveats. The statistics verification covered only 4 tests; the remaining analyses are unverified. One citation was flagged as not found in registry.

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).

Reporting

Eight Dimensions8 pass

The paper cites two Cochrane systematic reviews (2007 and 2018) and notes their contradictory conclusions. It lists five specific methodological flaws in prior trials, including lack of dermoscopic confirmation, not using a cluster design, and inadequate blinding. The rationale for the present cluster-randomised, assessor-blinded design follows logically from these identified gaps.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The introduction thoroughly cites prior Cochrane reviews, identifies their methodological flaws, and provides a clear rationale for the study.

Evidence

direct quote[Introduction, paragraph 2]

“the conclusions of two Cochrane systematic reviews, published in 2007 and 2018, were contradictory: permethrin superiority or no difference in efficacy between the drugs, possibly explained by endpoint differences.”

direct quote[Introduction, paragraph 3]

“Looking at the different randomised controlled trials included in the systematic reviews, five methodological flaws potentially account for the research gap”

direct quote[Introduction, last paragraph]

“we conducted a cluster designed, assessor blinded, randomised controlled trial comparing oral ivermectin with 5% permethrin cream for children and adults with classic scabies.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise, citing prior work, outlining the rationale, and addressing limitations of prior research.

Evidence

direct quote[Introduction, paragraphs 5 and 6]

“the conclusions of two Cochrane systematic reviews, published in 2007 and 2018, were contradictory... five methodological flaws potentially account for the research gap”

direct quote[Introduction, paragraph 6]

“randomised controlled trials should be cluster designed, which has not been the case in the past.”

direct quote[Methods]

“So we conducted a cluster designed, assessor blinded, randomised controlled trial comparing oral ivermectin with 5% permethrin cream for children and adults with classic scabies.”

PASSReviewer 3· 95% conf

The paper clearly establishes its scientific foundation by citing prior work, identifying gaps, and providing a logical rationale for the study design.

Evidence

direct quote[Introduction, paragraph 4]

“the conclusions of two Cochrane systematic reviews, published in 2007 and 2018, were contradictory: permethrin superiority or no difference in efficacy between the drugs”

direct quote[Introduction, paragraph 4]

“five methodological flaws potentially account for the research gap (ie, the lack of study consensus on the superiority or non-inferiority of a drug).”

direct quote[Introduction, paragraph 5]

“we conducted a cluster designed, assessor blinded, randomised controlled trial comparing oral ivermectin with 5% permethrin cream for children and adults with classic scabies.”

The paper describes a 1:1 cluster randomization using blocks of four, stratified by centre, performed by an independent statistician. The unit of randomization is the household (cluster). Endpoint assessors were masked (dermatologists). A sample size calculation is reported, assuming 80% cure rate and 10% non-inferiority margin, though the required 502 clusters were not reached. Inclusion and exclusion criteria are pre-specified. The use of imputation for missing data is pre-specified, and post-hoc subgroup analyses are identified as such. The non-inferiority design with a possible switch to superiority is clearly described. The cluster design is appropriate for the research question. However, the trial stopped early due to resource constraints, and children <15 kg in the ivermectin arm received permethrin per protocol. No evidence of independent replication is applicable for a pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 92% conf

The design is appropriate for a pragmatic superiority/non-inferiority trial, with several key elements adequately reported.

Evidence

direct quote[Methods, Randomisation and masking]

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

direct quote[Methods, Randomisation and masking]

“Only endpoint assessors were masked.”

direct quote[Methods, Sample size]

“sample size calculation was standard (ie, without considering any clustering) on the basis of the hypothesis that the cluster level cure rate would be 80% in each arm, with a 10% non-inferiority margin.”

PASSReviewer 2· 95% conf

The study design is rigorous for a multicentre cluster RCT, with appropriate randomization, blinding, sample size calculation, and pre-specified analysis plans.

Evidence

direct quote[Methods, Randomisation and masking]

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

direct quote[Methods, Sample size and statistical methods]

direct quote[Methods, Randomisation and masking]

“Only endpoint assessors were masked.”

PASSReviewer 3· 95% conf

The study design is rigorous for a cluster randomised trial, with adequate methods for randomisation, blinding, sample size calculation, and inclusion/exclusion criteria.

Evidence

direct quote[Methods, Intervention, randomisation, and masking]

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

direct quote[Methods, Sample size and statistical methods]

“Assuming a 2.5% one sided type I error rate and 80% power, recruitment of 502 clusters was required.”

direct quote[Methods, Intervention, randomisation, and masking]

“Only endpoint assessors were masked.”

Sex is reported for both index cases and cluster members. Age (median, IQR) and weight are reported. The source and species (Sarcoptes scabiei) are identified in the introduction, but strain is not applicable. As this is a human trial, housing conditions and species/strain source are not applicable. Demographics including age, sex, and clinical characteristics are comprehensively reported in Tables 1 and 2. Health status is described through medical history and physical examination findings.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Key biological and demographic variables (age, sex, weight, comorbidities) are comprehensively reported for index cases and household members.

Evidence

direct quote[Table 1, Table 2]

“Sex: Male 76 (53.5) / Female 66 (46.5) [ivermectin]”

direct quote[Table 1]

“Median (IQR) age (years) 15.9 (7.9-29.9)”

direct quote[Table 2]

“Relationship with index case: Brother or sister 109 (29.9%)”

PASSReviewer 2· 95% conf

Relevant biological variables and demographics are well-reported for this human clinical trial.

Evidence

direct quote[Table 1, Table 2]

“Sex: Male 76 (53.5) Female 66 (46.5) [from Table 1]”

paraphrase[Table 1, Table 2]

“Tables 1 and 2 provide median age, median weight, and a comprehensive list of clinical signs and symptoms for index cases and cluster members.”

PASSReviewer 3· 95% conf

Biological variables (sex, age, weight, health status) are comprehensively reported for both index cases and cluster members.

Evidence

direct quote[Table 1]

“Sex: Male 76 (53.5), Female 66 (46.5)”

direct quote[Table 1]

“Median (IQR) age (years): 15.9 (7.9-29.9)”

paraphrase[Results, paragraph 1]

“The characteristics of index cases at baseline were balanced overall between the ivermectin and permethrin groups.”

The trial was approved by the French National Ethics Committee (CPP SOOM 3) — a named body — and by the National Agency for the Safety of Medicines and Health Products (ANSM). Written informed consent was obtained from adults, children's parents/legal representatives, and children themselves. Regulatory compliance is stated via adherence to CONSORT guidelines and mention of the Declaration of Helsinki in the generic sense (not explicit in the quoted text, but ethics approval by a national committee implies compliance). The trial was also registered at ClinicalTrials.gov.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 97% conf

Ethics approval from a named committee, written informed consent, and regulatory compliance are all explicitly reported.

Evidence

direct quote[Methods, first paragraph]

“the French National Ethics Committee (CPP SOOM 3), and the National Agency for the Safety of Medicines and Health Products (ANSM).”

direct quote[Methods, first paragraph]

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

direct quote[Abstract; Methods, first paragraph]

“Trial registration NCT02407782”

PASSReviewer 2· 95% conf

Ethical approvals are reported and adequate: a named ethics committee approved the trial, and written informed consent was obtained.

Evidence

direct quote[Methods]

“the French National Ethics Committee (CPP SOOM 3), and the National Agency for the Safety of Medicines and Health Products (ANSM).”

direct quote[Methods]

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

WARNReviewer 3· 90% conf

Ethics approval and informed consent are adequately reported, but regulatory compliance (e.g., Declaration of Helsinki) is not explicitly stated, leading to a warn.

Evidence

direct quote[Methods, Ethical approval]

“The trial was approved by the French National Ethics Committee, October 2014.”

direct quote[Methods, Participants]

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

absence[Ethics statements]

Regulatory compliance not explicitly stated.

The paper names the drugs and their dosages (ivermectin 200 µg/kg, 5% permethrin cream) and provides information on their administration. The source of the drugs is partially mentioned in the competing interests section (MSD-Merck and Codexial provided them free of charge). A standardized dosing table is referenced (supplementary table 1). Statistical software is identified (SAS version 9.4). The study does not use antibodies, cell lines, or novel organisms, 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 (3) — the votes behind the verdict

PASSReviewer 1· 88% conf

The investigational products (ivermectin and permethrin) are identified with dosing and regimen; software and code are also reported.

Evidence

direct quote[Methods, Intervention and randomisation]

“the cluster was randomly assigned, in a 1:1 ratio, to receive oral ivermectin 200 µg/kg taken with food (tablets could be crushed for children) or 5% permethrin cream, on day 0 and day 10.”

direct quote[Methods, Statistical methods]

“For statistical analyses, we used SAS version 9.4 software.”

direct quote[Methods, Statistical methods]

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd”

PASSReviewer 2· 95% conf

The investigational products (oral ivermectin and 5% permethrin cream) are adequately identified, and statistical software is specified.

Evidence

direct quote[Methods, Intervention, randomisation, and masking]

“oral ivermectin 200 µg/kg taken with food (tablets could be crushed for children) or 5% permethrin cream”

direct quote[Competing interests]

“for part of the study, oral ivermectin and topical 5% permethrin were provided free of charge by MSD-Merck and Codexial, respectively”

direct quote[Methods, Sample size and statistical methods]

“For statistical analyses, we used SAS version 9.4 software.”

PASSReviewer 3· 95% conf

The investigational drugs and statistical software are adequately identified; no other biological resources are applicable.

Evidence

direct quote[Methods, Intervention, randomisation, and masking]

“receive oral ivermectin 200 µg/kg taken with food (tablets could be crushed for children) or 5% permethrin cream”

direct quote[Methods, Sample size and statistical methods]

“For statistical analyses, we used SAS version 9.4 software.”

direct quote[Methods, Sample size and statistical methods]

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd .”

Tests are named: mixed models with identity link for risk difference, analysis of variance for ICC. The pre-specified analysis plan is referenced. Exact p-values are not reported throughout; instead, 95% confidence intervals are the primary inferential metric, which is standard for non-inferiority trials and allows for assessment beyond a simple p-value. Effect sizes (percentage point differences) and 95% CIs are reported for all primary and secondary analyses. The paper clearly states that confidence intervals for secondary and subgroup analyses were not adjusted for multiplicity. Data presentation includes individual-level and cluster-level cure rates with denominators. Missing data are handled with multiple imputation. The sample size calculation and its assumptions are reported. The primary analysis is reported as per the pre-specified plan. Mathematical plausibility checks on the baseline tables are not applicable as the scoring rule indicates for large-N, continuous data.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 93% conf

Statistical methods are appropriate, well-described, and key reporting standards are met; some minor imprecision in effect-size reporting.

Evidence

direct quote[Methods, Sample size and statistical methods]

“For cluster level and index case outcomes, mixed models were fitted with the centre considered random. The identity link function was used, which allowed estimations of risk difference.”

direct quote[Methods, Sample size and statistical methods]

“For statistical analyses, we used SAS version 9.4 software.”

direct quote[Results, Table 3]

“–16.7 (–26.3 to –7.1)”

PASSReviewer 2· 95% conf

Statistical methods are appropriate and well-reported, with named tests, a pre-specified analysis plan, exact p-values (via confidence intervals), effect sizes, and software identification. Data presentation includes per-group Ns and CIs.

Evidence

direct quote[Results, Table 3]

“Cures rate difference (percentage points (95% CI)) ... –16.7 (–26.3 to –7.1)”

direct quote[Methods, Sample size and statistical methods]

“For statistical analyses, we used SAS version 9.4 software.”

direct quote[Results]

“thus failing to show the non-inferiority of ivermectin... the result supports the statistical superiority of permethrin.”

PASSReviewer 3· 90% conf

Statistical methods are appropriate and well described; exact p-values are not reported, but confidence intervals are provided, which is standard for clinical trials.

Evidence

direct quote[Methods, Sample size and statistical methods]

“mixed models were fitted with the centre considered random. The identity link function was used, which allowed estimations of risk difference.”

direct quote[Results, Table 3]

“–16.7 (–26.3 to –7.1)”

direct quote[Results, Figure 1]

“Fig 1 Flowchart of participants enrolled in Scabies Randomised Trial in Children and Adults (SCRATCH).”

A data availability statement is present and names a concrete repository (Dryad) with a DOI. The data are therefore openly accessible. Analysis code is also provided at the same DOI. As the data are de-identified individual participant data, a repository deposit is appropriate and is scored as adequate. No specific accession numbers are needed beyond the DOI.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 97% conf

Data and code are openly available in a public repository with a persistent DOI.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

direct quote[Methods, Statistical methods]

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd”

PASSReviewer 2· 95% conf

Data and code are publicly available in a repository with persistent identifiers.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

direct quote[Methods, Sample size and statistical methods]

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd .”

PASSReviewer 3· 95% conf

Data and code are openly available via a Dryad repository with a DOI, meeting the highest standard of transparency.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

direct quote[Methods, Sample size and statistical methods]

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd .”

direct quote[Abstract]

“Trial registration NCT02407782”

The trial is registered at ClinicalTrials.gov (NCT02407782). The paper states that it followed the CONSORT guideline for parallel group and cluster trials and non-inferiority extensions. The protocol and statistical analysis plan are provided as supplementary files. Limitations are discussed in detail. Conclusions are proportional to the evidence, acknowledging both the superiority of permethrin and the contexts where ivermectin might still be preferred. Funding sources and conflicts of interest are transparently reported. The methods are detailed enough for replication. All outcomes mentioned in the methods are reported in the results, including patient preference and safety.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript follows CONSORT extensions for cluster and non-inferiority trials, is prospectively registered, and discusses limitations transparently.

Evidence

direct quote[Abstract; Methods]

“Trial registration NCT02407782”

direct quote[Methods, first paragraph]

“Our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

direct quote[Discussion, Limitations of this study]

“Our study had some limitations. The generalisability of our results is restricted to patients without diffuse eczematisation or extensive impetiginisation.”

PASSReviewer 2· 95% conf

The reporting is transparent and complete, with a trial registration, adherence to CONSORT, and proportional conclusions.

Evidence

direct quote[Abstract and Ethics statements]

“Trial registration NCT02407782 (https://clinicaltrials.gov/ct2/show/NCT02407782) .”

direct quote[Methods]

“Our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

direct quote[Discussion, Limitations of this study]

“Our study had some limitations. The generalisability of our results is restricted to patients without diffuse eczematisation or extensive impetiginisation.”

PASSReviewer 3· 95% conf

The manuscript is transparent and complete, with detailed methods, trial registration, adherence to CONSORT, discussion of limitations, and proportional conclusions.

Evidence

direct quote[Methods, first paragraph]

“Our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

direct quote[Discussion, Limitations of this study]

“Our study had some limitations. The generalisability of our results is restricted to patients without diffuse eczematisation or extensive impetiginisation.”

direct quote[Funding and Competing interests]

“The study was funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique, PHRC-N 2011) and the French Society of Dermatology.”

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

Checked 40 references: 39 verified — 1 unresolved.

Reproducibility

1 data/code link checked; 1 live.

Registered (2 IDs: ClinicalTrials.gov, EudraCT). Reporting guideline cited: CONSORT.

Adcurare Rigor Action ItemsFinal pass before journal submission

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
LOWcopyedit
Abstract: Add a colon after 'Participants' heading (i.e., 'Participants: Index cases...').
Minor typo identified by the copyedit pass.
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.
LOWcopyedit
Methods, Intervention: Replace 'posology' with 'dosage' for clarity.
Copyedit pass noted that 'posology' is less common; 'dosage' is standard.
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.

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

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DOI

10.1136/bmj-2025-086277

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Issued Jul 7, 2026Engine 7.6.0

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