Rigor Reviewed

Rigor-Reviewed Manuscript

Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial.

Name: Adcurare Rigor Record — Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial.
Item: Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial.
Rating: 100
Author: Adcurare

Siu PM, Yu DJ, Yu AP, Recchia F, Li SX, Chan RN, Fong DY, Chan DK, Hui SS, Chung KF, Woo J, Wang C, Irwin MR

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Adcurare Rigor Review — 5★ (Exemplary), 0 critical, 5 high issues for “Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority 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

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

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

No specific rigor problems surfaced by the checks that ran.

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.

This is a well-designed and well-reported randomised non-inferiority trial comparing tai chi with CBT-I for insomnia. The main methodological strengths are the rigorous randomisation, pre-specified power analysis, ethical approvals, and data sharing. The main weaknesses are the lack of a specific CBT-I manual reference, unreported GEE model assumptions, and effect sizes reported without confidence intervals.

Evaluated as an interventional human trial. Several sub-criteria were not applicable (replicate distinction, independent replication, species strain source, housing conditions, antibodies identified, etc.). The two reviewers diverged on study design, key resources, and statistical analysis; the synthesized statuses reflect a balanced assessment of the available evidence. Statistics verification covered only 4 tests; no errors found but coverage is limited.

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

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

Reporting

Eight Dimensions8 pass

The Introduction provides a strong background on the burden of chronic insomnia, the established efficacy but limited accessibility of CBT-I, and the potential of tai chi as an accessible alternative. Prior studies on tai chi for insomnia are cited, noting they used passive controls and lacked direct comparison with CBT-I. The rationale for the non-inferiority design and the hypothesis are clearly stated. Limitations of prior research (lack of direct comparison with first-line treatment, lack of long-term data) are addressed by the study design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise, citing prior research on chronic insomnia prevalence, the limitations of CBT-I accessibility, and prior evidence for tai chi as a potential alternative.

Evidence

direct quote[Introduction, paragraphs 1-2]

“Cognitive behavioural therapy for insomnia (CBT-I) is the first line treatment for chronic insomnia owing to its excellent treatment efficacy and minimal side effects. However, accessibility to CBT-I is often limited because of the associated high costs and the low availability of trained therapists”

direct quote[Introduction, paragraph 3]

“Previous clinical trials and meta-analyses support the beneficial effects of tai chi in middle aged and older adults with insomnia... However, most studies used passive control designs (eg, stretching) or compared it with other exercise modalities (eg, aerobic exercise), while direct comparisons with first line insomnia treatments (eg, CBT-I) in middle aged and older adults with primary chronic insomnia are currently lacking.”

direct quote[Introduction, final paragraph]

“We hypothesised that tai chi is non-inferior to CBT-I for treating insomnia in middle aged and older adults, and sustaining the sleep improvements 12 months after the intervention.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior work on insomnia prevalence, CBT-I limitations, and tai chi evidence, with a logical rationale and hypothesis.

Evidence

direct quote[Introduction, paragraphs 1-3]

direct quote[Introduction, paragraph 3]

“most studies used passive control designs (eg, stretching) or compared it with other exercise modalities (eg, aerobic exercise), while direct comparisons with first line insomnia treatments (eg, CBT-I) in middle aged and older adults with primary chronic insomnia are currently lacking.”

direct quote[Introduction, last paragraph]

“We hypothesised that tai chi is non-inferior to CBT-I for treating insomnia in middle aged and older adults, and sustaining the sleep improvements 12 months after the intervention.”

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise by citing prior work on the prevalence of chronic insomnia, the limitations of CBT-I accessibility, and the potential of tai chi as an alternative, while also acknowledging gaps in direct comparisons.

Evidence

direct quote[Introduction, paragraph 1-2]

“Chronic insomnia is one of the most common sleep disorders... Cognitive behavioural therapy for insomnia (CBT-I) is the first line treatment... However, accessibility to CBT-I is often limited because of the associated high costs and the low availability of trained therapists.”

direct quote[Introduction, paragraph 4]

“However, most studies used passive control designs (eg, stretching) or compared it with other exercise modalities (eg, aerobic exercise), while direct comparisons with first line insomnia treatments (eg, CBT-I) in middle aged and older adults with primary chronic insomnia are currently lacking.”

direct quote[Introduction, paragraph 5]

“To validate the use of tai chi as an alternative approach... this study aimed to examine whether a three month tai chi intervention... is non-inferior to a three month CBT-I intervention... We hypothesised that tai chi is non-inferior to CBT-I for treating insomnia...”

The trial is a randomised, assessor-blinded, non-inferiority design. Randomisation used an online random generator with block sizes of 4-6, allocation concealment via sealed envelopes, and independent researchers. The sample size calculation is reported with power (95%), alpha (0.025), the non-inferiority margin (4 points, 50% of the minimally important difference), and assumptions from a pilot study. Inclusion and exclusion criteria are detailed. The primary analysis is per-protocol, with sensitivity analyses (intention-to-treat, LOCF, multiple imputation) and subgroup analyses. For a human RCT, blinding_levels is adequate: outcome assessors were blinded; participants and instructors were not blinded, which is justified by the nature of the interventions. Outlier handling is addressed via the pre-specified analysis populations, and controls are the active comparator (CBT-I). Replicate distinction and independent replication are not applicable for a human RCT.

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· 95% conf

The study design is rigorous: a randomised, assessor-blinded, non-inferiority trial with pre-specified sample size calculation, clear randomisation method, inclusion/exclusion criteria, and intention-to-treat and per-protocol analyses.

Evidence

direct quote[Methods, Randomisation and masking]

“Randomisation was conducted using an online random generator ( https://www.sealedenvelope.com/ ) with block sizes of four to six. The computer generated randomised allocation sequence was securely placed in sealed opaque envelopes and kept by an independent researcher”

direct quote[Methods, Statistical analysis: Sample size]

“We conducted sample size estimation for a two sample t test between tai chi and CBT-I interventions to detect non-inferiority using POWER in SAS OnDemand for Academics... The sample size estimation was based on a primary comparison of perceived insomnia severity measured by ISI between the two groups using a 95% power and 0.05/2=0.025 maximum chance of committing false type I errors”

direct quote[Methods, Randomisation and masking]

“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”

WARNReviewer 2· 85% conf

Randomization and blinding are well described, but the study lacks a pre-specified analysis population definition (ITT vs per protocol) for non-inferiority and does not report handling of missing data for the primary analysis beyond sensitivity analyses.

Evidence

direct quote[Methods, Randomisation and masking]

“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”

direct quote[Methods, Data analysis]

“Per protocol analyses were used to provide a more conservative and stringent non-inferiority comparison.”

PASSReviewer 3· 90% conf

The study design is rigorous for a non-inferiority trial, with clear randomization, allocation concealment, assessor blinding, a pre-specified power analysis, and detailed inclusion/exclusion criteria.

Evidence

direct quote[Methods, Randomisation and masking]

“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”

direct quote[Methods, Statistical analysis, Sample size]

“We conducted sample size estimation for a two sample t test between tai chi and CBT-I interventions to detect non-inferiority using POWER in SAS OnDemand for Academics... using a 95% power and 0.05/2=0.025 maximum chance of committing false type I errors... we needed a total of 70 participants in each group.”

The study reports sex, age (mean and SD), and comorbidities (physical and mental) in detail (Table 1). Age is reported in years. Health status is reported via several measures: BMI categories, insomnia severity index, sleep diary, actigraphy, and comorbidities. For a human interventional study, sex_justified is not applicable because both sexes were enrolled, and species_strain_source and housing_conditions are not applicable.

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· 95% conf

Key human demographic and health-related biological variables are adequately reported, including sex, age, BMI, and comorbidities.

Evidence

direct quote[Table 1]

“Female, n (%) | 77 (77) | 84 (84) | Age (years) | 64.83 (6.31) | 63.76 (6.15)”

direct quote[Table 1]

“Presented with physical comorbidities, n (%) | 62 (62) | 59 (59)”

PASSReviewer 2· 90% conf

Sex, age, BMI, and health status are reported. Sex is not justified because both sexes are included. Demographics are comprehensively reported.

Evidence

direct quote[Results, Table 1]

“Female, n (%): Tai chi 77 (77), CBT-I 84 (84); Age (years): 64.83 (6.31), 63.76 (6.15); Presented with physical comorbidities, n (%): 62 (62), 59 (59)”

PASSReviewer 3· 95% conf

Biological variables are well-reported for a human study, including sex, age, and detailed demographics. Sex is reported but not justified as single-sex, which is not applicable since both sexes are enrolled.

Evidence

direct quote[Table 1]

“Female, n (%) | 77 (77) | 84 (84) | | Age (years) | 64.83 (6.31) | 63.76 (6.15)”

direct quote[Table 1]

“Presented with physical comorbidities, n (%) | 62 (62) | 59 (59) | | Presented with mental comorbidities, n (%) | 13 (13) | 7 (7)”

The study was approved by the University of Hong Kong/Hospital Authority Hong Kong West institutional review board (IRB approval No UW 18-621). Written informed consent was obtained from all participants. The study states it was conducted in accordance with the Declaration of Helsinki. Regulatory compliance is mentioned. The trial was also prospectively registered (ClinicalTrials.gov NCT04384822).

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are fully reported: a named IRB provided approval, written informed consent was obtained, and compliance with the Declaration of Helsinki is stated.

Evidence

direct quote[Methods, Study design]

“The study was approved by the University of Hong Kong/Hospital Authority Hong Kong West institutional review board (IRB approval No UW 18-621).”

direct quote[Methods, Study design]

“Written informed consent was obtained on a voluntary basis before baseline assessments.”

direct quote[Methods, Study design]

“The study was conducted in accordance with the Declaration of Helsinki.”

PASSReviewer 2· 95% conf

Ethics approval from a named IRB with protocol number, written informed consent, and regulatory compliance with the Declaration of Helsinki are all reported.

Evidence

direct quote[Methods, Study design]

“The study was approved by the University of Hong Kong/Hospital Authority Hong Kong West institutional review board (IRB approval No UW 18-621).”

direct quote[Methods, Study design]

“Written informed consent was obtained on a voluntary basis before baseline assessments.”

direct quote[Methods, Study design]

“The study was conducted in accordance with the Declaration of Helsinki.”

PASSReviewer 3· 95% conf

Ethical approvals are fully reported: a named IRB with an approval number, written informed consent, and compliance with the Declaration of Helsinki are all stated.

Evidence

direct quote[Methods, Study design]

“The study was approved by the University of Hong Kong/Hospital Authority Hong Kong West institutional review board (IRB approval No UW 18-621).”

direct quote[Methods, Study design]

“Written informed consent was obtained on a voluntary basis before baseline assessments.”

direct quote[Methods, Study design]

“The study was conducted in accordance with the Declaration of Helsinki.”

This is a behavioural intervention trial; the 'key resources' are the two interventions. Both tai chi (24-form Yang style, certified instructors, 24 sessions) and CBT-I (typical components, certified therapists, 24 sessions) are described in sufficient detail for replication. The interventions are manualised (supplementary material II). No antibodies, cell lines, or organisms are used, so those sub-criteria are not applicable. Software is identified (SAS OnDemand for Academics, version not specified).

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The key resource in this clinical trial is the investigational product (tai chi intervention) and the active comparator (CBT-I), both of which are adequately described. No other bench reagents are applicable.

Evidence

direct quote[Methods, Interventions: Tai chi]

“The programme adopted the 24 form Yang style of tai chi... The intervention was prescribed as a three month programme consisting of a one hour session twice a week for a total of 24 sessions.”

direct quote[Methods, Interventions: Cognitive behavioural therapy for insomnia]

“The intervention covers typical CBT-I components, including sleep education, stimulus control, sleep restriction, relaxation training, and cognitive therapy.”

direct quote[Methods, Statistical analysis: Data analysis]

“All statistical analyses were performed using SAS OnDemand for Academics (SAS Institute).”

PASSReviewer 2· 90% conf

The investigational product (tai chi) is not a regulated drug/device, and no key biological/chemical resources are used. The software (SAS OnDemand) is identified with version. The paper passes on applicable criteria.

Evidence

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed using SAS OnDemand for Academics (SAS Institute).”

WARNReviewer 3· 85% conf

The investigational product (tai chi) and comparator (CBT-I) are described as interventions, but key resources like software are identified, while the specific details of the CBT-I program materials are not fully identified as a 'reagent'.

Evidence

direct quote[Methods, Interventions, Tai chi]

“The programme adopted the 24 form Yang style of tai chi, the most common style adopted in the literature.”

direct quote[Methods, Statistical analysis, Data analysis]

“All statistical analyses were performed using SAS OnDemand for Academics (SAS Institute).”

direct quote[Methods, Interventions, Cognitive behavioural therapy for insomnia]

“The intervention covers typical CBT-I components, including sleep education, stimulus control, sleep restriction, relaxation training, and cognitive therapy.”

Statistical tests are named (two-sample t-test for non-inferiority, GEE, logistic regression). Exact p-values are reported in Tables 2 and 3. Effect sizes (Cohen's d) and 95% confidence intervals are reported for the primary outcome. Statistical software is identified (SAS OnDemand for Academics). Data presentation includes per-group n, means, SDs, and CIs. For a large clinical trial, individual data points are not expected, and assumptions verification is handled by standard methods (GEE, logistic regression). The mathematical plausibility of summary statistics could not be independently verified due to continuous data and moderate N, but no obvious arithmetic impossibility is apparent.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical analyses are well-described with named tests, exact p-values (in tables), effect sizes (Cohen's d, confidence intervals), and software identified. The data presentation is appropriate for a clinical trial, with tables showing n, means, SDs, and CIs.

Evidence

direct quote[Methods, Statistical analysis: Data analysis]

“A non-inferiority analysis was performed on the primary outcome by comparing differences in the changes in ISI scores between the two groups at month 3 and month 15.”

paraphrase[Tables 2 and 3]

“Tables 2 and 3 report exact p-values for group, time, and interaction effects for all outcomes.”

direct quote[Tables 2 and 3]

“Cohen’s d† | Month 3 | Month 15”

WARNReviewer 2· 80% conf

Statistical tests are named, exact p-values are reported for key comparisons, and data presentation includes effect sizes and confidence intervals. However, effect sizes (Cohen's d) are reported without confidence intervals, and the per-protocol analysis for non-inferiority uses a one-sided confidence interval, which is appropriate. The paper is downgraded to warn because effect sizes lack CIs, and assumptions for the statistical models (GEE) are not discussed, with no report of how model assumptions were verified.

Evidence

direct quote[Methods, Data analysis]

“We used generalised estimating equations analyses to examine the treatment effects on the quantitative secondary outcomes, adjusting for baseline values.”

direct quote[Results, Tables 2 and 3]

“Cohen's d†: Month 3 -1.50, Month 15 -2.33 (for Tai chi, Insomnia Severity Index)”

absence[Results, Figure 2]

Individual data points not shown in figures.

PASSReviewer 3· 90% conf

Statistical analysis is rigorous with named tests, a pre-specified non-inferiority margin, exact p-values reported, and sensitivity analyses. Assumptions are not explicitly verified, but this is acceptable for a large clinical trial using standard methods.

Evidence

direct quote[Methods, Statistical analysis, Data analysis]

“A margin of 4 points in the ISI (50% of minimally important difference) was adopted to assess whether tai chi was non-inferior to CBT-I.”

direct quote[Results, Secondary outcomes]

“The insomnia remission rates differed between the CBT-I and tai chi groups at month 3 (83.3% v 56.1%, P<0.001) but were similar at month 15 (63.4% v 76.5%, P=0.067).”

direct quote[Table 2]

“Cohen's d† | Month 3 | Month 15 | | Tai chi | ... | −1.50 | −2.33”

The paper states: 'The data underlying the findings in this paper are openly and publicly available and can be found here: https://doi.org/10.6084/m9.figshare.29203967.v3'. This is a concrete repository (figshare) with a persistent identifier (DOI), which is reported_and_adequate for data_availability_statement and repository_deposit. The code is available in supplementary files, which is reported_but_inadequate as it is not in a version-controlled public repo with a permanent identifier, but it is still provided. Accession numbers are not applicable as this is not a sequencing study.

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The data are openly available in a repository with a DOI, and the code is available in supplementary files. The data availability statement is adequate.

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/10.6084/m9.figshare.29203967.v3 .”

direct quote[Data availability statement]

“The code used to analyse the data in the paper can be found in the supplementary files.”

PASSReviewer 2· 90% conf

Data availability statement names a public repository with a DOI, and the code is available as supplementary files. This exceeds the minimal requirement.

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/10.6084/m9.figshare.29203967.v3”

direct quote[Data availability statement]

“The code used to analyse the data in the paper can be found in the supplementary files.”

PASSReviewer 3· 90% conf

Data and code availability are well-addressed: a data availability statement is present, data are deposited in a public repository with a DOI, and code is available from the corresponding author and in supplementary files.

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/10.6084/m9.figshare.29203967.v3 .”

direct quote[Data availability statement]

“Statistical code and dataset are available from the corresponding author at pmsiu@hku.hk . The code used to analyse the data in the paper can be found in the supplementary files.”

The methods are comprehensive and include a published protocol paper. The trial is prospectively registered (NCT04384822). The paper adheres to the CONSORT extension for non-inferiority trials. All pre-specified outcomes (primary and secondary) are reported in tables, including non-significant results. Limitations are discussed (generalizability, single centre, cultural aspects). Conclusions appropriately state non-inferiority at 15 months but inferiority at 3 months. Funding sources and conflicts of interest are stated.

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· 95% conf

Reporting transparency is high: methods are detailed, the trial is registered, the CONSORT guideline is followed, all outcomes are reported, limitations are discussed, conclusions are proportional, and funding and conflicts of interest are disclosed.

Evidence

direct quote[Abstract, Methods]

“Trial registration ClinicalTrials.gov NCT04384822”

direct quote[Methods, Study design]

“This randomised, assessor blinded, non-inferiority trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) extension for non-inferiority and equivalence trials.”

direct quote[Discussion, Study limitations]

“A large proportion (77.5%, n=155) of the study participants were older adults aged ≥60 years, which might limit the generalisability of our results when considering younger populations.”

PASSReviewer 2· 90% conf

The trial is registered (NCT04384822), methods are detailed, CONSORT extension for non-inferiority is referenced, limitations are discussed, and funding/COI are declared. All applicable criteria are adequate.

Evidence

direct quote[Abstract and Methods]

“Trial registration ClinicalTrials.gov NCT04384822; This randomised, assessor blinded, non-inferiority trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) extension for non-inferiority and equivalence trials.”

direct quote[Discussion, Study limitations]

“This study has several potential limitations. A large proportion (77.5%, n=155) of the study participants were older adults aged ≥60 years, which might limit the generalisability of our results when considering younger populations.”

direct quote[Funding and Competing interests sections]

“This study was supported by General Research Fund of Research Grants Council, Hong Kong University Grants Committee (project No 17112819)... All authors have completed the ICMJE uniform disclosure form... and declare: support from... no financial relationships...”

PASSReviewer 3· 90% conf

Reporting is transparent: the trial is registered, a CONSORT extension is referenced, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

direct quote[Abstract, Methods]

“Trial registration ClinicalTrials.gov NCT04384822”

direct quote[Methods, Study design]

“This randomised, assessor blinded, non-inferiority trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) extension for non-inferiority and equivalence trials.”

direct quote[Discussion, Study limitations]

“A large proportion (77.5%, n=155) of the study participants were older adults aged ≥60 years, which might limit the generalisability of our results when considering younger populations.”

5 copyedit issues flagged: mostly consistency, clarity.

Checked 44 references: 43 verified — 1 not checked.

Reproducibility

3 data/code links checked; 3 live.

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is ready for submission after minor revisions. The primary issues are reporting gaps (CBT-I manual reference, GEE assumptions, effect size CIs) and a copyedit consolidation of the data availability statement. These are straightforward fixes and do not threaten the study's conclusions.

1.
HIGHreporting
In Methods, Interventions: Cognitive behavioural therapy for insomnia, add a reference to a specific published treatment manual or protocol (e.g., a citation or appendix) to enable replication of the CBT-I intervention.
Reviewers flagged that the CBT-I intervention is described only generically, which limits replicability.
2.
HIGHstatistics
In Methods, Statistical analysis: Data analysis, add a statement on how GEE model assumptions (e.g., working correlation structure selection, residual diagnostics) were verified.
GEE assumptions are not reported; this is a standard expectation for longitudinal analyses.
3.
HIGHstatistics
In Tables 2 and 3, add 95% confidence intervals for each Cohen's d effect size.
Effect sizes without confidence intervals provide incomplete information about precision and statistical significance.
4.
HIGHother
In Methods, Data analysis, provide a clear pre-specified definition of the per-protocol analysis population (e.g., what constitutes a protocol deviation and the criteria for exclusion).
The per-protocol population is not explicitly defined, which is important for the non-inferiority interpretation.
5.
HIGHother
In Methods, Data analysis, explicitly state how outliers were handled (e.g., whether any outlier analyses were performed or if none were needed, explain why).
Outlier handling is not reported; this is a gap in study design reporting.
6.
MEDIUMdata code
In the Data availability statement, consolidate the sentences about code availability into one clear statement: e.g., 'The analysis code is available in the supplementary files; the data are openly available at [figshare DOI].'
The current statement redundantly mentions code being available from the author and in supplementary files; a single statement is clearer.
7.
MEDIUMreporting
In Methods, Statistical analysis: Sample size, add a brief explanation for why 200 participants were enrolled instead of the planned 180 (e.g., 'anticipated additional dropout due to COVID-19 delays').
The copyedit noted a discrepancy between the planned and actual enrolment that could be clarified.
8.
MEDIUMreporting
In Methods, statistical analysis: Data analysis, specify the version of SAS OnDemand for Academics used.
Software version is important for reproducibility; the version is not currently stated.
9.
MEDIUMstatistics
Consider adding individual participant data points to the primary outcome figure (month 3 and month 15) to enhance data transparency.
Reviewer 2 noted that individual data points are not shown; this is a useful transparency enhancement.
10.
MEDIUMreporting
In the Data availability statement, add a note that the code is also available in the supplementary files and from the corresponding author to avoid redundancy.
The copyedit flagged this as a minor consistency issue.
11.
LOWcopyedit
In the Abstract, Results, rephrase 'The per protocol principle was adopted.' to 'The per-protocol principle was adopted for the primary analysis.' for clarity.
Copyedit suggestion to hyphenate 'per-protocol' when used as an adjective and be more specific.
12.
LOWreporting
In Methods, Statistical analysis, Data analysis, add a brief explanation of why per-protocol is more conservative for non-inferiority trials.
Copyedit suggestion, as this nuanced point may not be clear to all readers.

Full text (55,106 chars)Analyzed: Jul 7, 2026

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