Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial.
Arundel C, Mandefield L, Fairhurst C, Baird K, Gkekas A, Saramago P, Chetter I, SWHSI-2 Trial Investigators
- DOI
- 10.1016/S0140-6736(25)00143-6
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-21
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/66e94dd8-56af-4b28-8f3c-9cce4e61a0ea is authoritative.
How this rating was calculated
- IntegrityIntegrity concern−0.5★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 8 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.
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 well-reported pragmatic randomised controlled trial with a rigorous design, clear ethical approvals, and appropriate statistical methods. The main weaknesses are minor reporting gaps: the data availability DOI appears incorrect, the CONSORT guideline is not explicitly stated, and there is a small discrepancy in the adverse event counts between the abstract and Table 3.
Both reviewers independently scored all dimensions as pass, with high agreement. The study type is interventional (RCT). The statistics verification component checked 8 reported tests and found all consistent, but coverage is limited to tests with test statistics and df or effect estimates with CIs; threshold-only p-values and resampling-based p-values were not machine-verified. The citation check found no retracted or unresolved references.
Numerical inconsistencies
1 finding · worst lowValues 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 8 tests: 8 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 7 via agent-written checks.
- CONSISTENTreported p = .470 · recomputed p = .457Recomputed hazard ratio 1.08 (95% CI 0.88–1.32), reported p=0.47
“hazard ratio 1.08 [95% CI 0.88–1.32], p=0.47”
Taken as given: 0.88–1.32 is a two-sided 95% confidence interval for the hazard ratio of 1.08, not a range, an IQR, or a different interval level; the hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.47 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(1.08, 0.88, 1.32, 1) - CONSISTENTreported p = .360 · recomputed p = .361Reviewers 1, 2Secondary outcome masked assessment hazard ratio p-value
“HR 1·13 (0·87 to 1·47) | 0·36”
Taken as given: The HR is 1.13 and the 95% CI is 0.87 to 1.47.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed two-sided p-value from the hazard ratio and its 95% confidence interval using the normal approximation for the log hazard ratio.How we recomputed it: pCI(1.13, 0.87, 1.47, 1) - CONSISTENTreported p = .540 · recomputed p = .549Reviewer 2Hospital admission odds ratio p-value from CI
“OR 1·13 (0·76 to 1·69) | 0·54”
Taken as given: The OR is 1.13 with 95% CI 0.76 to 1.69.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the odds ratio and its 95% confidence interval using the normal approximation for the log odds ratio.How we recomputed it: pCI(1.13, 0.76, 1.69, 1) - CONSISTENTreported p = .350 · recomputed p = .342Reviewer 2Reoperation odds ratio p-value from CI
“OR 1·20 (0·82 to 1·74) | 0·35”
Taken as given: The OR is 1.20 with 95% CI 0.82 to 1.74.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the odds ratio and its 95% confidence interval using the normal approximation for the log odds ratio.How we recomputed it: pCI(1.20, 0.82, 1.74, 1) - CONSISTENTreported p = .950 · recomputed p = .936Reviewer 2Amputation odds ratio p-value from CI
“OR 0·98 (0·60 to 1·62) | 0·95”
Taken as given: The OR is 0.98 with 95% CI 0.60 to 1.62.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the odds ratio and its 95% confidence interval using the normal approximation for the log odds ratio.How we recomputed it: pCI(0.98, 0.60, 1.62, 1) - CONSISTENTreported p = .770 · recomputed p = .778Reviewer 2Wound infection odds ratio p-value from CI
“OR 1·05 (0·75 to 1·48) | 0·77”
Taken as given: The OR is 1.05 with 95% CI 0.75 to 1.48.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the odds ratio and its 95% confidence interval using the normal approximation for the log odds ratio.How we recomputed it: pCI(1.05, 0.75, 1.48, 1) - CONSISTENTreported p = .960 · recomputed p = .957Reviewer 2Antibiotic use odds ratio p-value from CI
“OR 1·01 (0·70 to 1·45) | 0·96”
Taken as given: The OR is 1.01 with 95% CI 0.70 to 1.45.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the odds ratio and its 95% confidence interval using the normal approximation for the log odds ratio.How we recomputed it: pCI(1.01, 0.70, 1.45, 1) - CONSISTENTreported p = .610 · recomputed p = .621Reviewer 2Death odds ratio p-value from CI
“OR 0·89 (0·56 to 1·41) | 0·61”
Taken as given: The OR is 0.89 with 95% CI 0.56 to 1.41.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Recomputed p-value from the odds ratio and its 95% confidence interval using the normal approximation for the log odds ratio.How we recomputed it: pCI(0.89, 0.56, 1.41, 1)
- lowinternal contradictionThe abstract reports 14 serious adverse events (nine in NPWT, five in usual care), but Table 3 reports 9 in NPWT and 4 in usual care, totalling 13. This discrepancy may be due to a typo or a difference in counting (e.g., one event not classified as serious in the table).
“There were 448 adverse events, of which 14 were serious (nine participants in the NPWT group and five participants in the usual care group); 124 were deemed potentially related to treatment.”
Table 3Find in source
Overstated conclusions
None foundConclusions 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.
Checked — nothing surfaced.
6 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewer 1There is no clear evidence that NPWT reduced the time to wound healing compared with usual care.The primary outcome HR of 1.08 (95% CI 0.88–1.32, p=0.47) directly supports this claim.Evidence: Primary outcome analysis: HR 1.08 (95% CI 0.88–1.32), p=0.47.
“There was no clear evidence that NPWT reduced the time to wound healing compared with usual care (hazard ratio 1·08 [95% CI 0·88–1·32], p=0·47).”
AbstractFind in source - supportedReviewers 1, 2NPWT was not cost-effective compared with usual care.The economic analysis shows a low probability of cost-effectiveness (47.2% at £20,000 threshold), supporting the claim.Evidence: Incremental net monetary benefit was negative and probability of cost-effectiveness was 47.2% at £20,000 threshold.
“The probability of NPWT being cost-effective is 47·2% at a £20 000 threshold, and 49·7% at a £30 000 threshold.”
ResultsFind in source - supportedReviewer 1These findings do not support the use of NPWT to augment SWHSI healing.The null primary outcome and lack of secondary benefits support this conclusion.Evidence: Primary outcome null, secondary outcomes null, and cost-effectiveness not demonstrated.
“These findings do not support the use of NPWT to augment SWHSI healing.”
AbstractFind in source - supportedReviewer 2NPWT did not reduce time to wound healing compared with usual care.The primary outcome analysis shows a hazard ratio of 1.08 (95% CI 0.88–1.32, p=0.47), which is not statistically significant, supporting the claim.Evidence: Primary outcome HR 1.08 (95% CI 0.88–1.32), p=0.47
“There was no clear evidence that NPWT reduced the time to wound healing compared with usual care (hazard ratio 1·08 [95% CI 0·88–1·32], p=0·47).”
AbstractFind in source - supportedReviewer 2NPWT should not be considered as a first-line treatment for lower limb SWHSI.The claim is supported by the lack of benefit in the primary outcome and secondary outcomes, and the cost-effectiveness analysis. The conclusion is appropriately cautious.Evidence: No significant differences in primary or secondary outcomes; cost-effectiveness probability <50%.
“This finding suggests that NPWT should not be considered as a first-line treatment for such patients in relation to wound healing.”
DiscussionFind in source - supportedReviewer 2The trial provides the first robust evaluation of NPWT for SWHSI.The paper cites a Cochrane review with only two small, low-quality trials, and this trial is large and multicentre, supporting the claim of being the first robust evaluation.Evidence: Cochrane review identified only two small, low-quality trials; this trial enrolled 686 participants across 29 centres.
“Considering the limitations in the quality of previous evidence, the SWHSI-2 trial provides the first robust evaluation of the effectiveness of NPWT as a treatment, in terms of time to healing, for patients with an SWHSI.”
DiscussionFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary outcome is time to wound healing, defined as complete epithelial cover, which is a direct clinical outcome, not a surrogate. The trial also includes hard clinical secondary outcomes such as amputation, death, and reoperation. Therefore, the efficacy claim is based on a hard clinical endpoint.
“The primary outcome was time to wound healing (days from randomisation to complete epithelial cover)”
- ADEQUATEEffect sizeThe study reports a hazard ratio of 1.08 (95% CI 0.88–1.32) for time to healing, with no statistically significant difference. The effect size is anchored to a prespecified target difference of 25% reduction in median healing time, which was considered clinically meaningful. The observed effect is small and not statistically significant, but the manuscript explicitly discusses the clinical meaningfulness and the lack of benefit.
“There was no clear evidence that NPWT reduced the time to wound healing compared with usual care (hazard ratio 1·08 [95% CI 0·88–1·32], p=0·47).”
Data authenticity concerns
None foundAn 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
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction and 'Research in context' sections cite a Cochrane systematic review that identified only two small, low-quality trials, and a meta-analysis of 48 low-quality studies, establishing the need for a robust RCT. The rationale for the trial is clearly linked to the absence of comparative evidence and the increasing use of NPWT. The paper explicitly addresses limitations of prior research, noting the small size, low quality, and risk of bias in previous studies, and the lack of adequate assessment of time to healing.
“A Cochrane systematic review of NPWT for SWHSI identified two small, low-quality randomised controlled trials and recommended caution when interpreting the findings and that further high-quality randomised controlled trials be conducted.”
“The use of NPWT for SWHSI has increased rapidly in recent years, with a 23% increase in use reported between 2012 and 2014; however, there is absence of robust supporting evidence regarding its clinical effectiveness and cost-effectiveness.”
“Both studies were small and at risk of bias due to limited reporting of healing events.”
“A Cochrane systematic review of NPWT for SWHSI identified two small, low-quality randomised controlled trials and recommended caution when interpreting the findings and that further high-quality randomised controlled trials be conducted.”
“In this pragmatic, open-label, multicentre, parallel-group, randomised, controlled trial (SWHSI-2) we aimed to undertake the first robust evaluation of the clinical and cost-effectiveness of NPWT compared with usual care (no NPWT) in treating SWHSI.”
“Both studies were small and at risk of bias due to limited reporting of healing events.”
Randomisation was performed via a centralised web-based system with variable block sizes, stratified by wound location, wound area, and centre. The unit of randomisation is the participant. Blinding was not possible for participants and clinical teams (open-label), but masked outcome assessment of wound photographs was used to minimise bias. A power calculation was reported, specifying a target HR of 1.32, 90% power, and 20% attrition, requiring 696 participants. Inclusion/exclusion criteria were pre-specified. Outlier handling is addressed through the pre-specified analysis population (ITT) and sensitivity analyses. The control group (usual care) serves as the comparator. Independent replication is not applicable for a single pivotal trial.
“Randomisation to NPWT or usual care (1:1) was stratified by wound location (foot and ankle, leg, abdomen, or other), wound area (<28 cm 2 or ≥28 cm 2 , calculated as the measurement arising from the longest part of the wound multiplied by the measurement for the widest part of the wound), and study centre, using variable block sizes (two, four, six, and eight).”
“Participants and the clinical and research teams were unmasked to treatment allocation. However, to minimise bias, masked assessment of wound healing photographs was completed by clinically experienced independent observers and analysis of this was included as a secondary outcome.”
“To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT equating to a hazard ratio [HR] of 1·32 and a control group event proportion of 0·95), with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, , , 696 participants were required (348 per group).”
“Randomisation to NPWT or usual care (1:1) was stratified by wound location (foot and ankle, leg, abdomen, or other), wound area (<28 cm 2 or ≥28 cm 2 , calculated as the measurement arising from the longest part of the wound multiplied by the measurement for the widest part of the wound), and study centre, using variable block sizes (two, four, six, and eight).”
“Participants and the clinical and research teams were unmasked to treatment allocation. However, to minimise bias, masked assessment of wound healing photographs was completed by clinically experienced independent observers and analysis of this was included as a secondary outcome.”
“To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT equating to a hazard ratio [HR] of 1·32 and a control group event proportion of 0·95), with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, , , 696 participants were required (348 per group).”
The trial reports sex (male/female), age (median and IQR), and demographics (ethnicity) in Table 1. Since both sexes are enrolled, sex_justified is not applicable. Age and health status (comorbidities) are reported. Species/strain and housing conditions are not applicable for a human trial. Demographics are adequately reported.
“The median participant age was 63 years (IQR 55–72), most participants were male (n=513, 74·8%), and of White ethnicity (n=630, 91·8%).”
“The median participant age was 63 years (IQR 55–72), most participants were male (n=513, 74·8%), and of White ethnicity (n=630, 91·8%).”
“Most participants were diabetic (n=549, 80·0%) and had a single SWHSI (n=622, 90·7%), located on the foot or leg (n=620, 90·4%), arising after vascular surgery (n=619, 90·2%).”
The paper states that the Yorkshire and Humber Leeds East Research Ethics Committee and UK Health Research Authority granted ethical approval with a reference number (19/YH/0054). Written informed consent was required from participants. Regulatory compliance is implied through the UK Health Research Authority approval, which is a recognised framework.
“The Yorkshire and Humber Leeds East Research Ethics Committee and UK Health Research Authority granted ethical approval (reference 19/YH/0054).”
“Eligible participants were required to give written informed consent.”
“The Yorkshire and Humber Leeds East Research Ethics Committee and UK Health Research Authority granted ethical approval (reference 19/YH/0054).”
“Eligible participants were required to give written informed consent.”
The NPWT device is described as CE-marked and providing 60–150 mm Hg pressure, but the specific model is not prescribed. This is adequate for a pragmatic trial where the device is chosen by the clinical team. Usual care dressings are described as routine wound care dressings without NPWT. Statistical software (R and Stata) is identified with versions. No antibodies, cell lines, or mycoplasma testing are applicable.
“A specific NPWT model was not prescribed; however, the device was required to be CE marked (ie, meeting legislative requirements for use in the UK and Europe) and to provide 60–150 mm Hg pressure.”
“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18)”
“A specific NPWT model was not prescribed; however, the device was required to be CE marked (ie, meeting legislative requirements for use in the UK and Europe) and to provide 60–150 mm Hg pressure.”
“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18) using two-sided significance tests at the 5% significance level, with parameter estimates presented with associated 95% CI and p values as appropriate.”
The primary analysis uses Kaplan-Meier curves and Cox proportional hazards regression, with the HR and 95% CI reported. Exact p-values are provided (e.g., p=0.47). Effect sizes are reported with 95% CIs. Statistical software is identified. Data presentation includes Kaplan-Meier curves, forest plots, and per-group n. Mathematical plausibility checks were not performed due to the large sample size and continuous outcomes, but no obvious inconsistencies were noted.
“The primary outcome (time to healing of the reference wound) was assessed using a Kaplan–Meier curve by group and the median time to healing and HR with 95% CIs was calculated using a proportional hazards Cox regression model in the coxme package.”
“HR 1·08 (0·88 to 1·32) | 0·47”
“The primary outcome (time to healing of the reference wound) was assessed using a Kaplan–Meier curve by group and the median time to healing and HR with 95% CIs was calculated using a proportional hazards Cox regression model in the coxme package.”
“HR 1·08 (0·88 to 1·32) | 0·47”
The data availability statement states that anonymised datasets will be stored in a publicly available open research repository (https://osf.io/echxv) and provides a DOI (10.1016/j.jvs.2013.06.073). This is a concrete access route. Repository deposit is planned, and the DOI serves as a persistent identifier. Accession numbers are not applicable for this type of data. Code sharing is not mentioned, but the statistical analysis plan is available via ISRCTN.
“Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv) . Data will be made available via this repository after completion of analysis and subsequent publication.”
“Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv) . Data will be made available via this repository after completion of analysis and subsequent publication.”
The trial is registered with ISRCTN (ISRCTN26277546). Methods are described in sufficient detail for replication. A reporting guideline (CONSORT) is implied by the trial profile figure, though not explicitly stated. All pre-specified outcomes are reported, including negative results. Limitations are thoroughly discussed, including the overrepresentation of lower limb wounds and the impact of COVID-19. Conclusions are proportional to the evidence, stating no clear evidence of benefit. Funding and conflicts of interest are declared.
“The trial was registered with ISRCTN, ISRCTN26277546.”
“Notably, there is an overrepresentation of patients with lower limb wounds, including those with complications of diabetes in the study sample.”
“This study was funded by the National Institute for Health Research Health Technology Assessment Programme (project reference 17/42/94).”
“The trial was registered with ISRCTN, ISRCTN26277546.”
“Notably, there is an overrepresentation of patients with lower limb wounds, including those with complications of diabetes in the study sample.”
Registered (1 ID: ISRCTN). No reporting guideline cited.
Broken references and links
None foundReferences 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.
Checked 27 references by DOI: 16 verified — 11 no DOI (shown, not verified).
- NO DOIBayesian econometric modelling of observational data for cost-effectiveness analysis: establishing the value of negative pressure wound therapy in the healing of open surgical woundsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIThe epidemiology, management and impact of surgical wounds healing by secondary intention: a research programme including the SWHSI feasibility RCTNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIUse of vacuum assisted closure therapy in the treatment of diabetic foot woundsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIThe MUST report: nutritional screening of adults a multidisciplinary responsibility. Development and use of the ‘Malnutrition Universal Screening Tool’ (‘MUST’) for adultsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOINutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition (CG32)No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIThe measurement and valuation of health status using EQ-5D: a European perspectiveNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIA retrospective study of pilonidal sinus healing by secondary intention using negative pressure wound therapy versus alginate or gauze dressingsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIcoxme: mixed effects Cox modelsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIA proportional hazards model for the subdistribution of a competing riskNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIBounds on treatment effects from studies with imperfect complianceNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIHealth technology evaluations: the manual. NICE process and methods (PMG36)No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- dataOSFLIVEHTTP 200https://osf.io/echxvResolves to OSF (data repository).
Copyediting
5 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 5 minor suggestions below.
5 copyedit issues flagged: mostly consistency, clarity, typo.
- MINORconsistencyData sharing section“Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv) . Data will be made available via this repository after completion of analysis and subsequent publication.”→ Remove the space before the period and ensure the DOI is correctly formatted.Minor formatting issue.
- MINORclarityResults, Table 2 footnote“Data are 25th percentiles as fewer than half of the participants had healing confirmed in this analysis set so a median could not be reported.”→ Clarify that this applies to the masked outcome assessment row.Ambiguity in table footnote.
- MINORconsistencyData sharing section“10.1016/j.jvs.2013.06.073”→ Replace with the correct OSF DOI (e.g., 10.17605/OSF.IO/ECHXV).The DOI appears to be from a journal article, not the repository.
- MINORclarityResults, Table 2 footnote“Data are 25th percentiles as fewer than half of the participants had healing confirmed in this analysis set so a median could not be reported.”→ Clarify that the values are 25th percentiles, not medians, in the table header.The footnote is clear but could be more prominent.
- MINORtypoAbstract, Findings“There were 448 adverse events, of which 14 were serious (nine participants in the NPWT group and five participants in the usual care group); 124 were deemed potentially related to treatment.”→ Ensure consistency with Table 3, which reports 9 serious adverse events in NPWT and 4 in usual care.The abstract says five in usual care, but Table 3 says four. This is a discrepancy.
The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps: the incorrect DOI in the data availability statement, the lack of explicit CONSORT adherence, and the small discrepancy in adverse event counts between the abstract and Table 3. These are not validity threats but warrant a correction or clarification.
- 1.HIGHdata codeCorrect the DOI in the Data sharing section: replace 10.1016/j.jvs.2013.06.073 with the correct OSF project DOI (e.g., 10.17605/OSF.IO/ECHXV).The current DOI appears to be from a journal article, not the repository, which undermines the data availability statement.
- 2.HIGHreportingReconcile the serious adverse event counts between the Abstract (14 total, 5 in usual care) and Table 3 (13 total, 4 in usual care) and correct the discrepancy.An internal contradiction in reported safety data could raise concerns about data integrity.
- 3.MEDIUMreportingExplicitly state adherence to CONSORT guidelines in the Methods or a dedicated section, and mention that the CONSORT checklist is available as supplementary material.Explicit reporting guideline adherence improves transparency and reproducibility.
- 4.MEDIUMdata codeAdd a statement about the availability of the statistical analysis plan (SAP) and any analysis code, even if the code is not shared, to enhance transparency.Code sharing is not mentioned, and a statement would improve reproducibility.
- 5.MEDIUMreportingClarify the Table 2 footnote to explicitly state that the values are 25th percentiles, not medians, in the table header.The current footnote is ambiguous and could be misinterpreted.
- 6.MEDIUMreportingIn the Discussion, explicitly acknowledge the lack of blinding as a potential source of bias, even though masked outcome assessment was used.Open-label design is a known limitation that should be explicitly discussed.
- 7.MEDIUMreportingClarify the generalisability of the findings to non-lower-limb SWHSI, given the overrepresentation of lower limb wounds, and suggest future research directions.The sample is predominantly lower limb wounds, which may limit generalisability.
- 8.LOWcopyeditRemove the space before the period in the Data sharing section: '...repository (https://osf.io/echxv) .'Minor formatting issue that should be corrected for professionalism.
- 9.LOWreportingConsider reporting the number of participants with missing data for each outcome in the tables, to improve transparency.Missing data reporting is a standard expectation for clinical trials.
- 10.LOWstatisticsProvide more detail on the statistical analysis plan, such as the exact model specifications for the mixed-effects models, to facilitate replication.Greater model specification detail would improve reproducibility.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
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Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
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