Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

Name: Kaimen Rigor review — Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.
Item: Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.
Rating: 59
Author: Alpha1

McGregor G, Sandhu H, Bruce J, Sheehan B, McWilliams D, Yeung J, Jones C, Lara B, Alleyne S, Smith J, Lall R, Ji C, Ratna M, Ennis S, Heine P, Patel S, Abraham C, Mason J, Nwankwo H, Nichols V, Seers K, Underwood M

Paper source

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Kaimen Rigor review — 2★ (Weak), 0 critical, 2 high issues for “Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

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DOI

10.1136/bmj-2023-076506

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

Paper source

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
StatisticsStatistic did not reproduce−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×12−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 32 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
44% does not match the reported count 108/220
“108 (44)”
Table 3
02Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary endpoint is the PROMIS-PROPr score, a patient-reported outcome measure (a surrogate for health-related quality of life). The paper does not demonstrate target engagement (PK/PD or dose-exposure) at the tested dose, nor does it cite validated evidence linking the PROMIS-PROPr score to a hard clinical outcome. The claim of clinical effectiveness rests on this surrogate without meeting both required conditions.
“The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months.”
Find in source
03Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary effect size is an adjusted mean difference of 0.03 (95% CI 0.01 to 0.05) in PROPr score, which the authors themselves note is smaller than the suggested minimally important difference of 0.04. The effect is not anchored to a clinically meaningful threshold; the authors rely on post-hoc analyses (CACE and NNT) to argue for clinical importance, but the primary result is below the established MCID.
“Our observed differences of 0.03 (95% confidence interval 0.01 to 0.05) at three months and 0.03 (0.01 to 0.06) at 12 months are smaller than this suggestion.”
Find in source
04Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
88% does not match the reported count 508/585
“508/585 (88%)”
Find in source
05Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
88% does not match the reported count 508/585
“508/585; 88%”
ResultsFind in source
06Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
34% does not match the reported count 77/212
“77 (34)”
Table 3

9 further findings of this severity or below — every one is in the sections below, filed under its error type.

Findings by category

301ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit6 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported pragmatic RCT of an online rehabilitation programme for post-covid-19 condition. The main methodological strength is the rigorous design with adequate randomization, blinding of outcome assessment, and pre-specified analyses. The primary weakness is the vague data availability statement and lack of code sharing, which limits reproducibility.

Both reviewers independently scored all eight dimensions and agreed on every status; no divergence required reconciliation. The statistics verification component covered only a subset of reported tests (those with test statistics/df or effect estimates with CIs); 13 of 17 tests were not machine-verifiable, so the absence of detected errors does not confirm overall statistical correctness. The citation check found no retracted or unresolved references.

Numerical inconsistencies

3 findings · worst high

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.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 3 tests: 3 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 2 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (PERCENT). 12 printed percentages that do not match their own count.

Overstated conclusions

3 findings · worst high

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.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

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.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites epidemiological data on long covid prevalence and symptoms, and notes that only small quasi-experimental studies have investigated exercise-based rehabilitation, with no high-quality definitive evidence. The rationale for a multicomponent physical and mental health rehabilitation programme is logically linked to the biopsychosocial model and evidence from other long-term conditions. The paper does not explicitly discuss limitations of prior research in detail, but the gap in evidence is clearly stated.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise, citing prior research and providing a logical rationale for the study.

Evidence

“Across the World Health Organization European Region during the first two years of the covid-19 pandemic, more than 17 million people may have experienced covid-19 symptoms lasting more than four weeks.”

Introduction ¶1Find in source

“The biopsychosocial model of care may contribute to improved outcomes for people with post-covid-19 condition. Multicomponent physical and mental health rehabilitation can improve breathlessness, fatigue, and quality of life in other long term conditions.”

Introduction ¶3Find in source

“To date, only small quasi-experimental studies have investigated exercise based rehabilitation interventions for people with post-covid-19 condition, and no high quality definitive evidence exists as to the potential benefits or harms of physical and mental health rehabilitation interventions.”

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior research and providing a logical rationale for the study.

Evidence

Introduction ¶1Find in source

Introduction ¶4Find in source

Introduction ¶3Find in source

Randomization used a centralised computer-generated sequence with minimisation, stratified by age, level of hospital care, and mental health symptomatology. Participants and practitioners were not masked, but outcome assessments were completed online or by staff blind to allocation. A sample size calculation was performed with 90% power and 5% type I error, accounting for clustering. Inclusion/exclusion criteria were pre-specified. Outlier handling is addressed through the pre-specified analysis population and multiple imputation for missing data. Controls are appropriate (usual care group). Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessment, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“participants were randomly allocated (1:1.03) to the REGAIN intervention or to usual care by a centralised computer generated randomisation sequence using a bespoke web based system, administered independently by Warwick Clinical Trials Unit.”

MethodsFind in source

“Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.”

MethodsFind in source

“Assuming an intracluster coefficient of 0.01, 90% power, and type I error rate of 5%, with a 10% loss to follow-up, we determined that 535 participants would be required.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessment, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.”

MethodsFind in source

“Assuming an intracluster coefficient of 0.01, 90% power, and type I error rate of 5%, with a 10% loss to follow-up, we determined that 535 participants would be required.”

MethodsFind in source

The paper reports sex (52% female), age (mean 56 years), ethnicity (88% white), and various comorbidities. Age and sex are reported for the study population. Since both sexes are enrolled, sex_justified is not applicable. Demographics are adequately reported. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, ethnicity, and comorbidities.

Evidence

“Mean age of the study sample was 56 (SD 12) years, more than half were female participants (305/585; 52%)”

Results ¶1Find in source

“most were of white ethnicity (517/585, 88%)”

Results ¶1Find in source

“The most common pre-existing medical conditions related to chest or breathing (444/585; 76%) and musculoskeletal conditions (275/585; 47%)”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, ethnicity, and comorbidities.

Evidence

“Mean age of the study sample was 56 (SD 12) years, more than half were female participants (305/585; 52%)”

Results ¶1Find in source

“most were of white ethnicity (517/585, 88%)”

Results ¶1Find in source

“The most common pre-existing medical conditions related to chest or breathing (444/585; 76%) and musculoskeletal conditions (275/585; 47%)”

Table 1Find in source

The study was approved by a named research ethics committee (East of England, Cambridge South Research Ethics Committee, reference 20/EE/0235) and the Health Research Authority. Informed consent is implied through the description of online consent procedures. Regulatory compliance is stated through adherence to the COPI regulations and good clinical practice.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are adequately reported.

Evidence

“This study was approved by the East of England, Cambridge South Research Ethics Committee (reference 20/EE/0235) and the Health Research Authority/Health and Care Research Wales on 6 November 2020.”

EthicsFind in source

“Participants then completed an online consent form and baseline outcomes questionnaire before randomisation.”

MethodsFind in source

“The NHS Digital “Digi-Trials” service was approved to identify and invite potential participants in accordance with Regulation 3(4) of the Health Service (Control of Patient Information, COPI) Regulations 2002”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and consent are adequately documented.

Evidence

EthicsFind in source

“Participants then completed an online consent form and baseline outcomes questionnaire before randomisation.”

MethodsFind in source

The REGAIN intervention is described in detail, including the delivery platform (Zoom/Beam) and the workbook URL. Statistical software (Stata version 17 and R version 4) is identified. No antibodies, cell lines, or mycoplasma testing are applicable. The intervention is a complex behavioural programme, not a drug or device, but it is still scored as the investigational product.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (REGAIN intervention) is described in detail, and software tools are identified.

Evidence

“The REGAIN intervention comprised an eight week, online, home based, supervised, group rehabilitation programme (see supplementary figure S1), supported by a workbook for participants ( https://wrap.warwick.ac.uk ).”

MethodsFind in source

“All analyses were conducted using Stata version 17 and R version 4.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational intervention is described in sufficient detail, including the platform and materials.

Evidence

“delivered through Zoom using the Beam platform ( https://www.beamfeelgood.com )”

MethodsFind in source

“supported by a workbook for participants ( https://wrap.warwick.ac.uk )”

MethodsFind in source

“Participants in the usual care group received best practice usual care, consisting of a 30 minute, online, one-to-one consultation with a trained practitioner.”

MethodsFind in source

The primary analysis used a partially nested heteroscedastic model, with adjustments for baseline and stratification variables. Tests are named (e.g., Mann-Whitney for normality violations). Exact p-values are reported for primary and secondary outcomes. Effect sizes with 95% confidence intervals are reported throughout. Statistical software is identified. Data presentation includes per-group n and confidence intervals. Mathematical plausibility checks were not possible for all values, but no obvious errors were found.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well reported, with effect sizes and confidence intervals provided.

Evidence

“For the primary outcome (PROPr score) we performed a partially nested heteroscedastic model to compare health related quality of life at three months between the REGAIN intervention group and usual care group, producing unadjusted and adjusted estimates.”

Statistical analysisFind in source

“adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02”

Results ¶2Find in source

“depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01)”

Results ¶2Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with effect sizes and confidence intervals reported.

Evidence

Statistical analysisFind in source

“adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02”

Results ¶2Find in source

“All analyses were conducted using Stata version 17 and R version 4.”

Statistical analysisFind in source

The data availability statement says 'Data are available on reasonable request from wctudataaccess@warwick.ac.uk' but does not specify conditions or timeframe, which is inadequate. No repository deposit or accession numbers are provided, and no code sharing is mentioned. For a clinical trial, managed access is acceptable, but the statement lacks detail.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data availability statement is present but vague, and no code is shared.

Evidence

“Data are available on reasonable request from wctudataaccess@warwick.ac.uk .”

Data availabilityFind in source

absence[Data availability statement]

No code sharing is mentioned.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, lacking a concrete access mechanism.

Evidence

“Data are available on reasonable request from wctudataaccess@warwick.ac.uk .”

Data availabilityFind in source

The trial is registered (ISRCTN11466448). Methods are detailed and reproducible. The paper follows CONSORT guidelines (implied by the flow diagram). All pre-specified outcomes are reported, including null results. Limitations are discussed in the discussion section. Conclusions are proportional to the evidence. Funding and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent, with trial registration, detailed methods, and discussion of limitations.

Evidence

“Trial registration ISRCTN registry ISRCTN11466448.”

AbstractFind in source

“Limitations include the inability of trial participants or practitioners delivering the intervention to be masked to treatment allocation.”

LimitationsFind in source

“This trial was funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme.”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ISRCTN registry ISRCTN11466448.”

AbstractFind in source

“Limitations include the inability of trial participants or practitioners delivering the intervention to be masked to treatment allocation.”

LimitationsFind in source

“This trial was funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme.”

FundingFind in source

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

Broken references and links

None found · partly checked

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 29 references by DOI: 24 verified — 5 no DOI (shown, not verified).

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported; an informed reader should weigh the vague data availability statement and lack of code sharing as the main reproducibility limitations. No erratum or correction appears warranted based on the checks performed, though the authors could strengthen the data access statement and share analysis code to improve transparency.

1.
HIGHdata code
In the Data availability statement, specify the conditions and timeframe for data access, e.g., 'Data are available on reasonable request from wctudataaccess@warwick.ac.uk after approval of a proposal and with a signed data access agreement.'
The current statement is vague and does not meet common reproducibility standards for clinical trials.
2.
HIGHdata code
Deposit de-identified aggregate data or statistical analysis code in a public repository (e.g., Zenodo) with a DOI.
Sharing data and code enhances reproducibility and is increasingly expected for funded trials.
3.
MEDIUMreporting
Explicitly state in the Methods that the study is reported following CONSORT guidelines and provide the checklist as supplementary material.
Explicit reporting guideline adherence improves transparency and completeness.
4.
MEDIUMreporting
In the Discussion, expand on the limitations of the PROPr score's minimal important difference, as the observed effect is below the suggested threshold.
This contextualizes the clinical significance of the primary outcome.
5.
MEDIUMstatistics
Clarify in the Methods, Statistical analysis, which outcome the Mann-Whitney test applies to, as the primary analysis uses a mixed model.
The current wording is ambiguous and could confuse readers about the analysis plan.
6.
LOWcopyedit
Ensure consistent spacing in p-values (e.g., P<0.001 vs P < 0.001) throughout the Abstract and Results.
Minor formatting consistency improves professional presentation.
7.
LOWcopyedit
Standardize hyphenation in Table 2 footnote: change 'ITT=intention to treat' to 'ITT=intention-to-treat'.
Consistency in abbreviations avoids confusion.
8.
LOWcopyedit
Rephrase the Discussion sentence about PROPr score for clarity: 'The PROPr score is calculated from seven PROMIS subscores; we also measured four separate PROMIS subscales.'
Improves readability and precision.

Full text (60,338 chars)Analyzed: Aug 16, 2026

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Read alongside

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

Read full text (PMC)

DOI

10.1136/bmj-2023-076506

Share this Kaimen Rigor review

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Record fingerprint

c30056f641dd1f495e3c7f16ee23f987318df08d686257bc4d2a5b8e89c866ba

Verify via API

Issued Aug 16, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

2 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
StatisticsStatistic did not reproduce−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×12−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 32 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
44% does not match the reported count 108/220
“108 (44)”
Table 3
02Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary endpoint is the PROMIS-PROPr score, a patient-reported outcome measure (a surrogate for health-related quality of life). The paper does not demonstrate target engagement (PK/PD or dose-exposure) at the tested dose, nor does it cite validated evidence linking the PROMIS-PROPr score to a hard clinical outcome. The claim of clinical effectiveness rests on this surrogate without meeting both required conditions.
“The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months.”
Find in source
03Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary effect size is an adjusted mean difference of 0.03 (95% CI 0.01 to 0.05) in PROPr score, which the authors themselves note is smaller than the suggested minimally important difference of 0.04. The effect is not anchored to a clinically meaningful threshold; the authors rely on post-hoc analyses (CACE and NNT) to argue for clinical importance, but the primary result is below the established MCID.
“Our observed differences of 0.03 (95% confidence interval 0.01 to 0.05) at three months and 0.03 (0.01 to 0.06) at 12 months are smaller than this suggestion.”
Find in source
04Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
88% does not match the reported count 508/585
“508/585 (88%)”
Find in source
05Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
88% does not match the reported count 508/585
“508/585; 88%”
ResultsFind in source
06Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
34% does not match the reported count 77/212
“77 (34)”
Table 3

9 further findings of this severity or below — every one is in the sections below, filed under its error type.

Findings by category

301ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit6 minor suggestions

Numerical inconsistencies

3 findings · worst high

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Overstated conclusions

3 findings · worst high

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise, citing prior research and providing a logical rationale for the study.

Evidence

Introduction ¶1Find in source

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior research and providing a logical rationale for the study.

Evidence

Introduction ¶1Find in source

Introduction ¶4Find in source

Introduction ¶3Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessment, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.”

MethodsFind in source

“Assuming an intracluster coefficient of 0.01, 90% power, and type I error rate of 5%, with a 10% loss to follow-up, we determined that 535 participants would be required.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessment, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.”

MethodsFind in source

“Assuming an intracluster coefficient of 0.01, 90% power, and type I error rate of 5%, with a 10% loss to follow-up, we determined that 535 participants would be required.”

MethodsFind 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· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, ethnicity, and comorbidities.

Evidence

“Mean age of the study sample was 56 (SD 12) years, more than half were female participants (305/585; 52%)”

Results ¶1Find in source

“most were of white ethnicity (517/585, 88%)”

Results ¶1Find in source

“The most common pre-existing medical conditions related to chest or breathing (444/585; 76%) and musculoskeletal conditions (275/585; 47%)”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, ethnicity, and comorbidities.

Evidence

“Mean age of the study sample was 56 (SD 12) years, more than half were female participants (305/585; 52%)”

Results ¶1Find in source

“most were of white ethnicity (517/585, 88%)”

Results ¶1Find in source

“The most common pre-existing medical conditions related to chest or breathing (444/585; 76%) and musculoskeletal conditions (275/585; 47%)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are adequately reported.

Evidence

EthicsFind in source

“Participants then completed an online consent form and baseline outcomes questionnaire before randomisation.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and consent are adequately documented.

Evidence

EthicsFind in source

“Participants then completed an online consent form and baseline outcomes questionnaire before randomisation.”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (REGAIN intervention) is described in detail, and software tools are identified.

Evidence

MethodsFind in source

“All analyses were conducted using Stata version 17 and R version 4.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational intervention is described in sufficient detail, including the platform and materials.

Evidence

“delivered through Zoom using the Beam platform ( https://www.beamfeelgood.com )”

MethodsFind in source

“supported by a workbook for participants ( https://wrap.warwick.ac.uk )”

MethodsFind in source

“Participants in the usual care group received best practice usual care, consisting of a 30 minute, online, one-to-one consultation with a trained practitioner.”

MethodsFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well reported, with effect sizes and confidence intervals provided.

Evidence

Statistical analysisFind in source

“adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02”

Results ¶2Find in source

“depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01)”

Results ¶2Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with effect sizes and confidence intervals reported.

Evidence

Statistical analysisFind in source

“adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02”

Results ¶2Find in source

“All analyses were conducted using Stata version 17 and R version 4.”

Statistical analysisFind in source

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data availability statement is present but vague, and no code is shared.

Evidence

“Data are available on reasonable request from wctudataaccess@warwick.ac.uk .”

Data availabilityFind in source

absence[Data availability statement]

No code sharing is mentioned.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, lacking a concrete access mechanism.

Evidence

“Data are available on reasonable request from wctudataaccess@warwick.ac.uk .”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent, with trial registration, detailed methods, and discussion of limitations.

Evidence

“Trial registration ISRCTN registry ISRCTN11466448.”

AbstractFind in source

“Limitations include the inability of trial participants or practitioners delivering the intervention to be masked to treatment allocation.”

LimitationsFind in source

“This trial was funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme.”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ISRCTN registry ISRCTN11466448.”

AbstractFind in source

“Limitations include the inability of trial participants or practitioners delivering the intervention to be masked to treatment allocation.”

LimitationsFind in source

“This trial was funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme.”

FundingFind in source

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

Broken references and links

None found · partly checked

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 29 references by DOI: 24 verified — 5 no DOI (shown, not verified).

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
In the Data availability statement, specify the conditions and timeframe for data access, e.g., 'Data are available on reasonable request from wctudataaccess@warwick.ac.uk after approval of a proposal and with a signed data access agreement.'
The current statement is vague and does not meet common reproducibility standards for clinical trials.
2.
HIGHdata code
Deposit de-identified aggregate data or statistical analysis code in a public repository (e.g., Zenodo) with a DOI.
Sharing data and code enhances reproducibility and is increasingly expected for funded trials.
3.
MEDIUMreporting
Explicitly state in the Methods that the study is reported following CONSORT guidelines and provide the checklist as supplementary material.
Explicit reporting guideline adherence improves transparency and completeness.
4.
MEDIUMreporting
In the Discussion, expand on the limitations of the PROPr score's minimal important difference, as the observed effect is below the suggested threshold.
This contextualizes the clinical significance of the primary outcome.
5.
MEDIUMstatistics
Clarify in the Methods, Statistical analysis, which outcome the Mann-Whitney test applies to, as the primary analysis uses a mixed model.
The current wording is ambiguous and could confuse readers about the analysis plan.
6.
LOWcopyedit
Ensure consistent spacing in p-values (e.g., P<0.001 vs P < 0.001) throughout the Abstract and Results.
Minor formatting consistency improves professional presentation.
7.
LOWcopyedit
Standardize hyphenation in Table 2 footnote: change 'ITT=intention to treat' to 'ITT=intention-to-treat'.
Consistency in abbreviations avoids confusion.
8.
LOWcopyedit
Rephrase the Discussion sentence about PROPr score for clarity: 'The PROPr score is calculated from seven PROMIS subscores; we also measured four separate PROMIS subscales.'
Improves readability and precision.

Full text (60,338 chars)Analyzed: Aug 16, 2026