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Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

Name: Kaimen Rigor review — Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.
Item: Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.
Rating: 95
Author: Alpha1

Jolly K, Clarke J, Crossland N, Dombrowski SU, Gkini E, Hoddinott P, Ingram J, Johnson D, MacArthur C, Mann M, McKell J, Moss N, Roberts T, Sanders J, Savory N, Sitch A, Taylor B, Tearne S, Thomson G, Williams E, Woolley R, ABA-feed study group

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Kaimen Rigor review — 4.25★ (Strong), 0 critical, 2 high issues for “Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

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DOI

10.1136/bmj-2025-086558

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

Paper source

Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingEthical approvals partially met−0.25★

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

Not verified in this report

References were not verified against Crossref/OpenAlex.
The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit7 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 is a well-conducted and transparently reported RCT with a clear premise, robust design, and comprehensive statistical analysis. The main rigor gaps are the absence of an explicit regulatory compliance statement (e.g., Declaration of Helsinki) and a reference to a reporting guideline, both minor omissions. The copyedit issues are minor.

Both independent reviewers agreed on all dimensions except for a minor sub-criterion disagreement on biological variables (age weight health), which was resolved by considering the study context. The evaluation is based on the full published paper.

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 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

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.

Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 1 warn

The introduction cites the 2022 Cochrane review on breastfeeding support, notes that previous UK trials of peer support showed no benefit, and identifies possible reasons (low intensity, lack of proactive support). The ABA-feed intervention was developed to address these issues. Strengths and weaknesses of prior work are acknowledged, and the rationale for the study is logically linked to the evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior research, including a Cochrane review and previous UK trials, and explains how the current intervention addresses limitations of prior work.

Evidence

“Despite international evidence for the effectiveness of peer support on any and exclusive breastfeeding rates, several large randomised controlled trials of peer support in the UK did not show a beneficial effect.”

Introduction ¶3Find in source

paraphrase[Introduction, paragraph 4]

“The ABA-feed (Assets based feeding help Before and After birth-feed) intervention of infant feeding peer support was developed to deal with these issues, drawing on best evidence including a moderate to high number of proactive woman centred antenatal and postnatal contacts, underpinned by behaviour change theory and an assets based approach.”

paraphrase[Introduction, paragraph 5]

“The study aimed to evaluate whether this novel, intensive peer support intervention could improve breastfeeding rates in a UK context.”

PASSReviewer 2· 90% conf

The premise is well established through a detailed introduction citing WHO recommendations, a 2022 Cochrane review, and prior UK peer-support trials, with a clear rationale for the novel intervention.

Evidence

“Several large randomised controlled trials of peer support in the UK did not show a beneficial effect. Possible reasons include low intensity interventions, lack of timely support after the birth, and the need for a new parent to initiate contact.”

Introduction ¶2Find in source

“The ABA-feed (Assets based feeding help Before and After birth-feed) intervention of infant feeding peer support was developed to deal with these issues”

Introduction ¶4Find in source

Randomisation was via a secure central web-based system with a 1.43:1 ratio and minimisation for site and age. The trial is unblinded, which is appropriate for a pragmatic behavioural intervention. A detailed sample size calculation is provided (90% power, 5% significance, ICC 0.039). Inclusion/exclusion criteria are clearly defined. Handling of missing data (imputed as formula feeding) and outliers (sensitivity analyses, bootstrapping) are described.

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 study design is rigorous: central randomisation with minimisation, a priori power analysis, pre-specified inclusion/exclusion criteria, and sensitivity analyses for missing data and outliers.

Evidence

“To ensure concealment of treatment allocation, the Birmingham Clinical Trials Unit used a secure, central, web based randomisation system to allocate women in a 1.43:1 ratio to receive intervention or usual care.”

MethodsFind in source

“Assuming 90% power and a two sided 5% significance level, with a control group rate of 44% for the primary outcome (95% CI 30.0% to 58.7%; from ABA feasibility data), a sample size of 2136 women (1068 in each group) was required to detect a risk ratio of 1.16 (ie, an increase of 7%).”

MethodsFind in source

“Regardless of their feeding intention, women were eligible for recruitment if they were nulliparous, between 20 weeks and 35 weeks and six days gestation with a singleton pregnancy, aged 16 years or older, and lived in the study area.”

MethodsFind in source

PASSReviewer 2· 90% conf

A well-designed human RCT with central web-based randomised allocation using minimisation, a detailed a priori sample-size calculation, explicit unblinded design, and clear eligibility and missing-data handling.

Evidence

“the Birmingham Clinical Trials Unit used a secure, central, web based randomisation system to allocate women in a 1.43:1 ratio to receive intervention or usual care”

MethodsFind in source

paraphrase[Methods, Sample size]

“Assuming 90% power and a two sided 5% significance level, with a control group rate of 44% for the primary outcome ... a sample size of 2136 women (1068 in each group) was required”

“Missing data were imputed as formula feeding for the primary outcome, excluding pregnancy losses, still births, infant deaths, or maternal deaths.”

Statistical analysisFind in source

All participants were nulliparous women (sex inherent to the breastfeeding population), with mean age 30.6 years reported in both arms. Demographics are extensive (ethnicity, education, employment, family status, deprivation index, feeding intentions). Health/gestational status is defined by eligibility (20-35 weeks gestation, singleton pregnancy). Sex justification is inherent to a breastfeeding trial, so marked not applicable. Species/housing criteria do not apply to human participants.

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· 80% conf

Sex and detailed demographics are reported, but weight/health status is not explicitly provided. Age is reported, which is sufficient for this study type.

Evidence

paraphrase[Methods, Recruitment and participants]

“Regardless of their feeding intention, women were eligible for recruitment if they were nulliparous...”

paraphrase[Results, Table 1]

“Mean (SD) age (years) | 30.6 (4.7) | 30.6 (4.8) | ... Ethnic group, highest level of qualification, family status, etc.”

absence[Results, Baseline characteristics]

Weight or health status not reported.

PASSReviewer 2· 85% conf

Participant characteristics are comprehensively reported for this human trial, including age, ethnicity, education, employment, family status, and deprivation.

Evidence

“Mean age of the participants was 30 years, and most described their ethnicity as white (2132; 86.5%)”

Table 1Find in source

“women were eligible for recruitment if they were nulliparous, between 20 weeks and 35 weeks and six days gestation with a singleton pregnancy, aged 16 years or older”

MethodsFind in source

The trial was approved by a named ethics committee (East of Scotland Research Ethics Committee, reference 21/ES/0045). Informed consent procedures are described in detail. However, no statement of adherence to the Declaration of Helsinki or other regulatory framework is provided, which is a minor omission for a clinical trial.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

Ethics approval and informed consent are reported, but the paper does not explicitly state compliance with a recognised regulatory framework such as the Declaration of Helsinki.

Evidence

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

EthicsFind in source

“Informed consent was obtained from each participant in person or by telephone or video call.”

MethodsFind in source

absence[Methods, Ethical approval]

No statement of regulatory compliance found.

WARNReviewer 2· 70% conf

A named research ethics committee approval with protocol number and informed consent are reported, but no explicit regulatory-compliance statement (e.g., Declaration of Helsinki) is provided.

Evidence

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

EthicsFind in source

“Informed consent was obtained from each participant in person or by telephone or video call.”

MethodsFind in source

absence[Ethics statements]

No adherence to a named regulatory framework is stated.

The intervention is peer support (behavioural). No investigational medicinal product, device, or biological reagent is used. The peer supporters are volunteers, not a resource to be catalogued. Software tools (SAS, Stata) are identified in the statistical analysis section, but this is a software tool for analysis, not a key resource for the intervention. The trial meets the criteria for not_applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedN/A

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 95% conf

The study is a behavioural intervention trial with no drug, biologic, device, or bench reagent; thus no key biological or chemical resources are applicable.

Evidence

paraphrase[Methods, intervention description]

“The intervention is a proactive peer support service delivered by volunteers, with no drugs, devices, or laboratory reagents.”

N/AReviewer 2· 90% conf

This is a behavioral/procedural peer-support trial with no drug, biologic, device, bench reagent, or bespoke software, so no key biological/chemical resource criteria apply.

Evidence

paraphrase[Methods, ABA-feed intervention]

“Paraphrase: The intervention is entirely behavioural (peer support contacts, assets leaflets); no drug, biologic, device, or bench reagent is described.”

The paper names all statistical tests (mixed effects log binomial, Cox proportional hazards, mixed effects linear regression, bootstrapping). Exact p-values are reported (e.g., P=0.69, P=0.13). Effect sizes are reported with 95% confidence intervals. Software (SAS 9.4, Stata 18) is identified. Data presentation includes per-group n, percentages, means, medians, IQRs, and CIs. No mathematical implausibilities were detected. Assumptions are handled through model choice and sensitivity analyses.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are comprehensive: tests are named, exact p-values and effect sizes with CIs are reported, software is identified, and data presentation follows clinical trial standards.

Evidence

paraphrase[Methods, Statistical analysis]

“The primary outcome (any breastfeeding at eight weeks after birth) was binary, and the planned analysis was to use a mixed effects log binomial regression model...”

“Any breastfeeding at 8 weeks after birth | 1013 (69.8) | 698 (68.8) | 1.01 (0.96 to 1.06; 0.77) | 0.01 (−0.03 to 0.04; 0.69)”

Table 3Find in source

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Statistical methods are comprehensively reported with named models, exact p-values, effect estimates with 95% CIs, identified software, and internally consistent summary statistics.

Evidence

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

Statistical analysisFind in source

“69.8% v 68.8%; risk difference 0.01, 95% CI −0.03 to 0.04, P=0.69”

ResultsFind in source

“All percentages presented do not include missing data.”

Table 1Find in source

The paper states that deidentified individual participant data are stored at a university repository (https://edata.bham.ac.uk/1555/) and are accessible for ethically approved research after registration. This is a concrete route. The statistical analysis code is included in the supplementary file. No accession numbers are needed for this type of data.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data availability statement is present with a concrete access route, and statistical analysis code is provided in the supplementary file.

Evidence

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

Data availabilityFind in source

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

PASSReviewer 2· 80% conf

A concrete data-availability statement names a repository with conditions, and the statistical analysis code is provided in the supplementary file.

Evidence

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

Data availabilityFind in source

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

The trial is registered (ISRCTN17395671). Methods are detailed enough for replication. All pre-specified outcomes are reported, including non-significant results. Limitations and strengths are discussed in a dedicated section. Conclusions are proportional to the evidence. The paper does not explicitly state adherence to a reporting guideline, which is a minor omission.

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

The paper is well-reported with trial registration, clear methods, all outcomes reported, limitations discussed, and proportional conclusions. However, no explicit mention of a reporting guideline (e.g., CONSORT) is made.

Evidence

“Trial registration ISRCTN Registry ISRCTN17395671.”

AbstractFind in source

“A limitation was that we did not fully achieve recruitment numbers to reach 90% power but did exceed the target for 80% power.”

LimitationsFind in source

absence[Methods]

No reporting guideline referenced.

PASSReviewer 2· 85% conf

The trial is registered, methods are detailed, all outcomes (including null results) are reported, limitations are thoroughly discussed, and funding/COI statements are complete.

Evidence

“Trial registration ISRCTN Registry ISRCTN17395671.”

AbstractFind in source

“A limitation was that we did not fully achieve recruitment numbers to reach 90% power but did exceed the target for 80% power.”

LimitationsFind in source

absence[Manuscript (throughout)]

No explicit CONSORT checklist statement.

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

Broken references and links

None found

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.

Checked — nothing surfaced.

1 data/code link checked; 1 live.

Copyediting

7 minor

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

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly punctuation, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published study is robust and trustworthy. Readers should note the minor omissions: no explicit statement of adherence to the Declaration of Helsinki, and no reference to the CONSORT checklist. The statistical analyses are consistent and the data/code are accessible. No validity-threatening errors were found; an erratum adding the regulatory compliance statement would be a minor improvement.

1.
HIGHethics
Add a statement of adherence to the Declaration of Helsinki (or equivalent) in the Ethics section; this could be submitted as a correction to the journal.
Standard requirement for clinical trials; missing statement is a reporting gap that readers and journal editors may note.
2.
HIGHreporting
Reference the CONSORT 2010 checklist in the Methods section to explicitly state adherence; this could be added via a correction.
Improves reporting transparency and meets journal requirements for randomised trials.
3.
MEDIUMcopyedit
Correct 'In additional to usual care' to 'In addition to usual care' in the Methods section (ABA-feed intervention).
Corrects a grammatical error that could distract readers.
4.
MEDIUMcopyedit
In Table 3, insert a semicolon before the P-value in the rows where it is missing (e.g., '0.96 (0.89 to 1.03 0.29)' should be '0.96 (0.89 to 1.03; P=0.29)').
Standard formatting for clarity and consistency.
5.
MEDIUMcopyedit
Remove the redundant 'text' in 'SMS text' and correct to 'SMS' in the Methods section.
Improves clarity and avoids redundancy.
6.
MEDIUMcopyedit
Fix the duplicated word in Table 3 footnote: 'Value >0 favour favours planned ABA-feed intervention' should be 'Value >0 favours planned ABA-feed intervention'.
Corrects a typo that could cause confusion.
7.
LOWstatistics
In the Abstract or Results, note the minor inconsistency between the risk ratio CI lower bound of 1.00 and the reported p=0.13 for breastfeeding initiation; this is likely a rounding artifact from the model boundary and could be clarified in a supplementary note.
Transparency for readers who may notice the discrepancy.

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Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

Read full text (PMC)

DOI

10.1136/bmj-2025-086558

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Record fingerprint

2b297b48c43a9933dbe8f492f12094a33f020bcd0ffc471bf923caf8ea35a254

Verify via API

Issued Aug 10, 2026Engine 7.29.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingEthical approvals partially met−0.25★

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

Not verified in this report

References were not verified against Crossref/OpenAlex.
The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit7 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

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

Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

Introduction ¶3Find in source

paraphrase[Introduction, paragraph 4]

paraphrase[Introduction, paragraph 5]

“The study aimed to evaluate whether this novel, intensive peer support intervention could improve breastfeeding rates in a UK context.”

PASSReviewer 2· 90% conf

Evidence

Introduction ¶2Find in source

“The ABA-feed (Assets based feeding help Before and After birth-feed) intervention of infant feeding peer support was developed to deal with these issues”

Introduction ¶4Find 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 study design is rigorous: central randomisation with minimisation, a priori power analysis, pre-specified inclusion/exclusion criteria, and sensitivity analyses for missing data and outliers.

Evidence

MethodsFind in source

PASSReviewer 2· 90% conf

Evidence

“the Birmingham Clinical Trials Unit used a secure, central, web based randomisation system to allocate women in a 1.43:1 ratio to receive intervention or usual care”

MethodsFind in source

paraphrase[Methods, Sample size]

“Assuming 90% power and a two sided 5% significance level, with a control group rate of 44% for the primary outcome ... a sample size of 2136 women (1068 in each group) was required”

“Missing data were imputed as formula feeding for the primary outcome, excluding pregnancy losses, still births, infant deaths, or maternal deaths.”

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· 80% conf

Sex and detailed demographics are reported, but weight/health status is not explicitly provided. Age is reported, which is sufficient for this study type.

Evidence

paraphrase[Methods, Recruitment and participants]

“Regardless of their feeding intention, women were eligible for recruitment if they were nulliparous...”

paraphrase[Results, Table 1]

“Mean (SD) age (years) | 30.6 (4.7) | 30.6 (4.8) | ... Ethnic group, highest level of qualification, family status, etc.”

absence[Results, Baseline characteristics]

Weight or health status not reported.

PASSReviewer 2· 85% conf

Participant characteristics are comprehensively reported for this human trial, including age, ethnicity, education, employment, family status, and deprivation.

Evidence

“Mean age of the participants was 30 years, and most described their ethnicity as white (2132; 86.5%)”

Table 1Find in source

“women were eligible for recruitment if they were nulliparous, between 20 weeks and 35 weeks and six days gestation with a singleton pregnancy, aged 16 years or older”

MethodsFind in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

Ethics approval and informed consent are reported, but the paper does not explicitly state compliance with a recognised regulatory framework such as the Declaration of Helsinki.

Evidence

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

EthicsFind in source

“Informed consent was obtained from each participant in person or by telephone or video call.”

MethodsFind in source

absence[Methods, Ethical approval]

No statement of regulatory compliance found.

WARNReviewer 2· 70% conf

A named research ethics committee approval with protocol number and informed consent are reported, but no explicit regulatory-compliance statement (e.g., Declaration of Helsinki) is provided.

Evidence

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

EthicsFind in source

“Informed consent was obtained from each participant in person or by telephone or video call.”

MethodsFind in source

absence[Ethics statements]

No adherence to a named regulatory framework is stated.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedN/A

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 95% conf

The study is a behavioural intervention trial with no drug, biologic, device, or bench reagent; thus no key biological or chemical resources are applicable.

Evidence

paraphrase[Methods, intervention description]

“The intervention is a proactive peer support service delivered by volunteers, with no drugs, devices, or laboratory reagents.”

N/AReviewer 2· 90% conf

This is a behavioral/procedural peer-support trial with no drug, biologic, device, bench reagent, or bespoke software, so no key biological/chemical resource criteria apply.

Evidence

paraphrase[Methods, ABA-feed intervention]

“Paraphrase: The intervention is entirely behavioural (peer support contacts, assets leaflets); no drug, biologic, device, or bench reagent is described.”

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are comprehensive: tests are named, exact p-values and effect sizes with CIs are reported, software is identified, and data presentation follows clinical trial standards.

Evidence

paraphrase[Methods, Statistical analysis]

“The primary outcome (any breastfeeding at eight weeks after birth) was binary, and the planned analysis was to use a mixed effects log binomial regression model...”

“Any breastfeeding at 8 weeks after birth | 1013 (69.8) | 698 (68.8) | 1.01 (0.96 to 1.06; 0.77) | 0.01 (−0.03 to 0.04; 0.69)”

Table 3Find in source

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Statistical methods are comprehensively reported with named models, exact p-values, effect estimates with 95% CIs, identified software, and internally consistent summary statistics.

Evidence

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

Statistical analysisFind in source

“69.8% v 68.8%; risk difference 0.01, 95% CI −0.03 to 0.04, P=0.69”

ResultsFind in source

“All percentages presented do not include missing data.”

Table 1Find in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data availability statement is present with a concrete access route, and statistical analysis code is provided in the supplementary file.

Evidence

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

Data availabilityFind in source

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

PASSReviewer 2· 80% conf

A concrete data-availability statement names a repository with conditions, and the statistical analysis code is provided in the supplementary file.

Evidence

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

Data availabilityFind in source

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

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

Evidence

“Trial registration ISRCTN Registry ISRCTN17395671.”

AbstractFind in source

“A limitation was that we did not fully achieve recruitment numbers to reach 90% power but did exceed the target for 80% power.”

LimitationsFind in source

absence[Methods]

No reporting guideline referenced.

PASSReviewer 2· 85% conf

The trial is registered, methods are detailed, all outcomes (including null results) are reported, limitations are thoroughly discussed, and funding/COI statements are complete.

Evidence

“Trial registration ISRCTN Registry ISRCTN17395671.”

AbstractFind in source

“A limitation was that we did not fully achieve recruitment numbers to reach 90% power but did exceed the target for 80% power.”

LimitationsFind in source

absence[Manuscript (throughout)]

No explicit CONSORT checklist statement.

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

Broken references and links

None found

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.

Checked — nothing surfaced.

1 data/code link checked; 1 live.

Copyediting

7 minor

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

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly punctuation, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHethics
Add a statement of adherence to the Declaration of Helsinki (or equivalent) in the Ethics section; this could be submitted as a correction to the journal.
Standard requirement for clinical trials; missing statement is a reporting gap that readers and journal editors may note.
2.
HIGHreporting
Reference the CONSORT 2010 checklist in the Methods section to explicitly state adherence; this could be added via a correction.
Improves reporting transparency and meets journal requirements for randomised trials.
3.
MEDIUMcopyedit
Correct 'In additional to usual care' to 'In addition to usual care' in the Methods section (ABA-feed intervention).
Corrects a grammatical error that could distract readers.
4.
MEDIUMcopyedit
In Table 3, insert a semicolon before the P-value in the rows where it is missing (e.g., '0.96 (0.89 to 1.03 0.29)' should be '0.96 (0.89 to 1.03; P=0.29)').
Standard formatting for clarity and consistency.
5.
MEDIUMcopyedit
Remove the redundant 'text' in 'SMS text' and correct to 'SMS' in the Methods section.
Improves clarity and avoids redundancy.
6.
MEDIUMcopyedit
Fix the duplicated word in Table 3 footnote: 'Value >0 favour favours planned ABA-feed intervention' should be 'Value >0 favours planned ABA-feed intervention'.
Corrects a typo that could cause confusion.
7.
LOWstatistics
In the Abstract or Results, note the minor inconsistency between the risk ratio CI lower bound of 1.00 and the reported p=0.13 for breastfeeding initiation; this is likely a rounding artifact from the model boundary and could be clarified in a supplementary note.
Transparency for readers who may notice the discrepancy.

Full text (65,205 chars)Analyzed: Aug 10, 2026