Rigor Reviewed

Rigor-Reviewed Manuscript

Provision of knee bracing for knee osteoarthritis (PROP OA): multicentre, parallel group, superiority, statistician blinded, randomised controlled trial.

Name: Adcurare Rigor Record — Provision of knee bracing for knee osteoarthritis (PROP OA): multicentre, parallel group, superiority, statistician blinded, randomised controlled trial.
Item: Provision of knee bracing for knee osteoarthritis (PROP OA): multicentre, parallel group, superiority, statistician blinded, randomised controlled trial.
Rating: 100
Author: Adcurare

Holden MA, Nicholls E, Abdali Z, Birrell F, Borrelli B, Callaghan M, Dziedzic K, Felson D, Foster NE, Halliday N, Ingram C, Jinks C, Jowett S, Peat G, PROP OA trial team

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Adcurare Rigor Review — 5★ (Exemplary), 0 critical, 3 high issues for “Provision of knee bracing for knee osteoarthritis (PROP OA): multicentre, parallel group, superiority, statistician blinded, randomised controlled 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.

The manuscript is a well-designed pragmatic RCT with strong methodology in most dimensions. It scores well on scientific premise, study design, biological variables, ethics, key resources, and statistical analysis, with only minor gaps in data code availability (code in supplementary files not a permanent repository) and reporting transparency (no explicit CONSORT mention or dedicated limitations section).

Three independent reviewer evaluations using a prespecified eight-dimension checklist were synthesised. The statistics verification component checked 5 tests (all consistent) but coverage is limited to tests with a test statistic and degrees of freedom, or an effect estimate with a 95% CI; threshold-only p-values and resampling-based methods could not be verified. The citation check found no retracted or missing references. The copyedit pass flagged 4 minor issues (formatting, consistency).

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

Recomputed 5 tests: 5 consistent, 0 inconsistent, 5 via agent-written checks.

Reporting

Eight Dimensions8 pass

The introduction cites international guidelines, systematic reviews, and prior trials, noting that evidence is sparse and guidelines are conflicting. It states that previous reviews were inconclusive due to limitations such as risk of bias, small sample sizes, and short follow-up. The rationale for the PROP OA trial is explicitly linked to the need for a large, high-quality RCT with longer follow-up. The hypothesis is clearly stated: compartment-specific bracing with adherence support is superior to advice and exercise alone. The limitations of prior work are acknowledged and addressed in the trial design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study clearly establishes its scientific foundation by citing prior research, acknowledging conflicting guidelines, and identifying gaps in the evidence base that the trial aims to address.

Evidence

direct quote[Introduction, paragraph 2]

“Internationally, clinical guidelines offer conflicting recommendations on the use of knee bracing for knee osteoarthritis, and evidence from high quality randomised controlled trials is sparse.”

direct quote[Introduction, paragraph 3]

“The PROP OA trial was designed to answer the need for a large, independent, high quality randomised controlled trial with outcomes for >6 months.”

direct quote[What is already known on this topic]

“Previous systematic reviews have been inconclusive because of limitations in existing trials, such as risk of bias, small sample sizes, short follow-up, and lack of targeting of adherence.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior work, providing a logical rationale, and addressing limitations of previous research.

Evidence

direct quote[Introduction, paragraph 3]

“Internationally, clinical guidelines offer conflicting recommendations on the use of knee bracing for knee osteoarthritis, and evidence from high quality randomised controlled trials is sparse.”

direct quote[Introduction, paragraph 3]

“The Provision of Braces for Patients with Knee Osteoarthritis (PROP OA) trial was designed to answer the need for a large, independent, high quality randomised controlled trial with outcomes for >6 months.”

direct quote[What is already known on this topic]

“Previous systematic reviews have been inconclusive because of limitations in existing trials, such as risk of bias, small sample sizes, short follow-up, and lack of targeting of adherence”

PASSReviewer 3· 95% conf

The scientific premise is well established, citing conflicting guidelines and sparse high-quality evidence to justify the trial.

Evidence

direct quote[Introduction, paragraph 2]

“Internationally, clinical guidelines offer conflicting recommendations on the use of knee bracing for knee osteoarthritis, and evidence from high quality randomised controlled trials is sparse.”

direct quote[What is already known on this topic]

“Previous systematic reviews have been inconclusive because of limitations in existing trials, such as risk of bias, small sample sizes, short follow-up, and lack of targeting of adherence”

direct quote[Introduction, paragraph 3]

Randomisation was computerised, stratified, with permuted blocks, and allocation concealed. The trial was open-label but the statistician was blinded, with a rationale for the lack of participant/therapist blinding. A power analysis was performed with a target sample size of 434 to detect a 0.35 effect size at 90% power. Inclusion and exclusion criteria are detailed, and the analysis follows a pre-specified plan with a treatment policy estimand (ITT). Outlier handling is addressed through multiple imputation and sensitivity analyses for missing data. The design is appropriate for a superiority trial.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

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 robust for a pragmatic RCT, with clear randomisation, blinding of the statistician, a priori power analysis, and detailed inclusion/exclusion criteria.

Evidence

direct quote[Methods: Randomisation and masking]

“We used a computerised web based randomisation service and random number generator, stratified by clinic site, predominant compartmental distribution of knee osteoarthritis, and the presence of instability (buckling), with a 1:1 allocation with random permuted blocks of sizes 2, 4, and 6.”

direct quote[Methods: Randomisation and masking]

“Although masking participants or physiotherapists to treatment allocation was not possible, the trial statistician was masked to treatment allocation.”

direct quote[Methods: Sample size]

“The trial was powered to detect an effect size between groups of 0.35 (small-to-medium effect) in KOOS-5 at six months with two sided 5% significance and 90% power.”

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, stratification, pre-specified inclusion/exclusion criteria, a power analysis, and a statistician-blinded approach.

Evidence

direct quote[Methods: Randomisation and masking]

“We used a computerised web based randomisation service and random number generator, stratified by clinic site, predominant compartmental distribution of knee osteoarthritis (based on a combination of clinical assessment and radiographic presentation), and the presence of instability (buckling), with a 1:1 allocation with random permuted blocks of sizes 2, 4, and 6.”

direct quote[Methods: Randomisation and masking]

“Although masking participants or physiotherapists to treatment allocation was not possible, the trial statistician was masked to treatment allocation.”

direct quote[Methods: Sample size]

“The trial was powered to detect an effect size between groups of 0.35 (small-to-medium effect) in KOOS-5 at six months with two sided 5% significance and 90% power.”

PASSReviewer 3· 95% conf

Study design is rigorous: randomised, statistician blinded, with a power analysis, pre-specified inclusion/exclusion criteria, and a clear analysis population.

Evidence

direct quote[Methods: Randomisation and masking]

“We used a computerised web based randomisation service and random number generator, stratified by clinic site, predominant compartmental distribution of knee osteoarthritis (based on a combination of clinical assessment and radiographic presentation), and the presence of instability (buckling), with a 1:1 allocation with random permuted blocks of sizes 2, 4, and 6.”

direct quote[Methods: Randomisation and masking]

“Although masking participants or physiotherapists to treatment allocation was not possible, the trial statistician was masked to treatment allocation.”

direct quote[Methods: Sample size]

“The trial was powered to detect an effect size between groups of 0.35 (small-to-medium effect) in KOOS-5 at six months with two sided 5% significance and 90% power.”

Table 1 reports sex (46% female), mean age (64 years), BMI (mean 29.0), comorbidities, and detailed demographics (ethnicity, deprivation index, etc.). Both sexes are included, so a justification for single-sex is not required. The variables are reported for both groups and are well-balanced.

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 biological variables including sex, age, weight, health status, and demographics are comprehensively reported in baseline tables.

Evidence

paraphrase[Table 1]

“Paraphrase: Table 1 shows mean age 64 (SD 9) years, 46% female participants, mean BMI 29.0, and a range of comorbidities and health conditions.”

direct quote[Table 1]

“Ethnic group: White 449 (97), Indian 4 (1), Pakistani 2 (0), Chinese 3 (1). Left school to attend full time education or university 195 (42). Index of multiple deprivation group: Group 1 (most deprived) 56 (12).”

PASSReviewer 2· 95% conf

Demographics (age, sex, ethnicity, comorbidities) are well-reported. Sex is reported and the sample includes both sexes, so justification for single sex is not applicable.

Evidence

direct quote[Results, Table 1]

“Mean (SD) age (years) 64 (9); Female participants 213 (46); Body mass index: Mean (SD) 29.0 (5.6)”

PASSReviewer 3· 95% conf

Key biological variables (sex, age, BMI, health status) and demographics (ethnicity, socioeconomic status) are well reported.

Evidence

direct quote[Abstract]

“466 participants (mean age 64 (standard deviation 9) years; 46% female participants)”

direct quote[Table 1]

“Ethnic group: White 449 (97)... Left school to attend full time education or university 195 (42)... Index of multiple deprivation group: Group 1 (most deprived): 1-6568 56 (12)”

direct quote[Table 1]

“Long term (>12 months) physical or mental health condition, disability, or illness: 210 (46)... Body mass index: Mean (SD) 29.0 (5.6)... Hospital Anxiety and Depression Scale: anxiety (0-21): Mean (SD) 5.4 (4.0)”

The paper states: 'The study was approved by North West Preston Research Ethics Committee, the Health Research Authority, and Health and Care Research in Wales (research ethics committee reference 19/NW/0183; Integrated Research Application System reference 247370).' Informed consent was obtained by the physiotherapist before data collection and randomization. Regulatory compliance is implied by the approvals from HRA and HCRW, which are UK regulatory bodies.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

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

Evidence

direct quote[Ethics statements]

“The study was approved by North West Preston Research Ethics Committee, the Health Research Authority, and Health and Care Research in Wales (research ethics committee reference 19/NW/0183; Integrated Research Application System reference 247370).”

direct quote[Methods: Participants]

“The physiotherapist obtained written informed consent from participants before collection of self-reported baseline data (including sex, defined as female, male, or other), randomisation, and delivery of the interventions.”

absence[Ethics statements]

Regulatory compliance statement is absent (no explicit mention of Declaration of Helsinki or similar framework).

PASSReviewer 2· 95% conf

Ethical approval is documented with a named committee and reference number. Informed consent is described. Regulatory compliance is stated.

Evidence

direct quote[Ethics statements]

direct quote[Methods: Participants]

“The physiotherapist obtained written informed consent from participants before collection of self-reported baseline data”

PASSReviewer 3· 95% conf

Ethical approval and informed consent are clearly documented with a named ethics committee and reference number.

Evidence

direct quote[Ethics statements]

direct quote[Methods: Participants]

The knee braces used are specified by manufacturer and model (Bioskin Q Brace, Össur Unloader One, Donjoy Nano, Össur Formfit Knee Hinged). The dose/regimen is described. Statistical software is identified as Stata version 18.0. No antibodies, cell lines, or organisms were used, so those sub-criteria are not applicable. Both applicable criteria are adequately reported.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational product (knee braces) is identified with manufacturer and model, and statistical software is named with version; other resource categories are not applicable.

Evidence

direct quote[Methods: Intervention]

“Participants were then given a patellofemoral (Bioskin Q Brace), tibiofemoral unloading (first choice brace was Össur Unloader One and second choice brace was Donjoy Nano), or a neutral stabilising knee brace (Össur Formfit Knee Hinged).”

direct quote[Methods: Statistical analysis]

“Data were analysed with Stata version 18.0.”

WARNReviewer 2· 90% conf

The investigational product (knee braces) is named with manufacturer and model, but no lot numbers, formulation details, or full identification of all brace types is provided. The AIE intervention is not a resource. Software is identified with version.

Evidence

direct quote[Methods: Intervention: AIE+B]

direct quote[Methods: Statistical analysis]

“Data were analysed with Stata version 18.0.”

PASSReviewer 3· 95% conf

The investigational product (knee braces) and software are identified with manufacturer and version, meeting the criteria for a device trial.

Evidence

direct quote[Methods: Intervention: AIE+B]

direct quote[Methods: Statistical analysis]

“Data were analysed with Stata version 18.0.”

The primary analysis uses longitudinal mixed models, clearly described. Adjusted mean differences with 95% CIs are reported for all outcomes. Model assumptions (normality, residuals) are discussed: 'All model assumptions were largely satisfied in the data, despite the raw scores for some outcomes not following a normal distribution.' Software is Stata 18.0. Data presentation includes tables with per-group means, SDs, and Ns. Exact p-values are not always given in the text but confidence intervals are, allowing inference. Mathematical plausibility checks: the percentages in ethnicity and other categorical variables sum to 100%, and the numbers are consistent with the stated Ns. No arithmetic implausibility is detected.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are well described, effect sizes and confidence intervals are reported, and assumptions are addressed; however, exact p-values are not reported, which is a minor omission.

Evidence

direct quote[Methods: Statistical analysis]

“Longitudinal mixed models were used to estimate treatment effects for primary and secondary outcomes at the three, six, and, 12 month follow-up periods, with results presented as adjusted mean differences and effect sizes, or adjusted odds ratios.”

direct quote[Table 4 footnote]

“All model assumptions were largely satisfied in the data, despite the raw scores for some outcomes not following a normal distribution. Some evidence exists indicating a correlation between the model residuals and the random intercept, and hence models were fitted with an unstructured covariance matrix and robust standard errors.”

absence[Results and Table 4]

Exact p-values are not reported; only confidence intervals are given.

PASSReviewer 2· 95% conf

Statistical tests are named, assumptions are addressed, exact p-values and 95% CIs are reported, effect sizes are given, software is identified, and data are presented with per-group n and SD. Mathematical plausibility is not flagged.

Evidence

direct quote[Methods: Statistical analysis]

direct quote[Results, Table 4]

“AIE v AIE+B: adjusted mean difference (95% CI) 3.39 (0.96 to 5.82)”

PASSReviewer 3· 85% conf

Statistical methods are appropriate and well described, with the exception that exact p-values are not reported (only confidence intervals); however, this is compensated by the use of CIs and effect sizes.

Evidence

direct quote[Methods: Statistical analysis]

direct quote[Table 4 footnote]

direct quote[Results and Table 4]

“At six months, greater improvement in KOOS-5 was seen in the AIE+B group than in the AIE group (adjusted mean difference 3.39, 95% confidence interval (CI) 0.96 to 5.82; effect size 0.24).”

A data availability statement is present with a direct link to the data repository (DOI: 10.21252/9tpn-8970). The code used for analysis is included in supplementary web appendices (Stata format and text format). No accession numbers are needed as no sequencing data were generated. All applicable criteria are adequately reported.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are openly available: data are deposited in a repository with a DOI, and analytical code is provided as 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/10.21252/9tpn-8970.”

direct quote[Data availability statement]

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

PASSReviewer 2· 95% conf

Data are openly available via a DOI. Code is available in supplementary files. The data availability statement is concrete.

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/10.21252/9tpn-8970 .”

direct quote[Data availability statement]

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

WARNReviewer 3· 85% conf

Data are openly available via a DOI, but the code is only provided in supplementary files rather than a version-controlled public repository, falling short of the ideal standard.

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/10.21252/9tpn-8970”

direct quote[Data availability statement]

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

absence[Data availability statement]

No accession numbers are provided (not applicable for this type of data).

The trial registration number is in the abstract. A published protocol is referenced. One secondary outcome (social participation from PROMIS) was erroneously omitted; this is transparently reported. Limitations are discussed in the results and discussion (e.g., covid-19 impact, adherence diminishing over time, clinician-assessed compartment). Conclusions are proportional: 'small improvements' and 'potential treatment option'. Funding (NIHR HTA) and competing interests are fully disclosed. No reporting guideline checklist is explicitly mentioned (CONSORT) but the paper follows CONSORT structure.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

The manuscript is generally transparent, with a trial registration, detailed methods, and proportional conclusions; however, it does not reference a reporting checklist or explicitly discuss limitations of the current study.

PASSReviewer 2· 95% conf

The trial is registered (ISRCTN28555470), methods are complete, all outcomes are reported (with one transparently noted omission: social participation not collected), limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

direct quote[Abstract]

“Trial registration ISRCTN28555470.”

direct quote[Methods: Study design]

“social participation (from Patient Reported Outcomes Measurement Information System, PROMIS) was an intended secondary outcome, but was erroneously not included in any follow-up questionnaires, and therefore cannot be reported as a secondary outcome.”

direct quote[Abstract: Conclusions]

“Adding compartment specific knee bracing and an adherence intervention to advice, written information, and exercise instruction resulted in small improvements in patient reported outcomes among individuals with knee osteoarthritis.”

PASSReviewer 3· 85% conf

The manuscript is transparent and well-reported, with a trial registration, detailed methods, and proportional conclusions, though it lacks an explicit mention of a reporting guideline and a dedicated limitations section.

Evidence

direct quote[Abstract and Methods]

“Trial registration ISRCTN28555470.”

direct quote[Methods: Study design]

absence[Entire manuscript]

No explicit mention of CONSORT or other reporting guideline.

4 copyedit issues flagged: mostly consistency, other, clarity.

Checked 35 references: 30 verified — 5 not checked.

Reproducibility

2 data/code links checked; 2 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is ready for submission after addressing a short list of pre-submission actions: moving the analysis code to a persistent repository, adding a CONSORT reporting guideline reference, adding a dedicated limitations section, and making minor copyedit fixes. No critical methodological problems were identified.

1.
HIGHdata code
Upload the analysis code to a version-controlled public repository (e.g., GitHub, Zenodo, or the same institutional repository that hosts the data) and update the Data Availability Statement to include the repository link and persistent identifier.
Code in supplementary files is not independently citable or version-controlled; a persistent repository ensures long-term access and reproducibility.
2.
HIGHreporting
Add an explicit statement in the Methods section that the trial report follows CONSORT guidelines, and provide the completed CONSORT checklist as a supplementary file.
Journals and readers expect reference to the applicable reporting guideline; its absence may trigger a reviewer request and delays.
3.
HIGHreporting
Add a dedicated 'Strengths and Limitations' subsection to the Discussion that transparently addresses potential biases (e.g., open-label design, contamination in the AIE group who received motivational interviewing), generalisability, and the impact of COVID-19 adaptations.
A dedicated limitations section is a standard element of a complete clinical trial report and helps readers interpret the findings appropriately.
4.
MEDIUMreporting
Report exact p-values (e.g., p=0.006) alongside the 95% confidence intervals for all primary and key secondary outcomes in the Results and Tables 4–5.
While confidence intervals are sufficient for inference, some meta-analysts and funders require exact p-values; their absence may be noted during peer review.
5.
MEDIUMreporting
Add the Bristol Online Tool or another validated adherence measurement instrument reference to complement the description of the adherence intervention (motivational interviewing).
This would strengthen the methodology description and allow others to replicate the adherence component.
6.
MEDIUMreporting
In the Abstract, consider adding a brief statement of the study's limitations to balance the conclusions.
Abstracts are frequently read in isolation; a limitations sentence helps prevent overinterpretation.
7.
MEDIUMcopyedit
In the Methods: Randomisation and masking section, rephrase 'Although masking participants or physiotherapists to treatment allocation was not possible ...' to 'Masking of participants and physiotherapists was not feasible due to the nature of the intervention; however, the trial statistician was blinded to treatment allocation.'
Improves clarity and flow of a key methodological statement.
8.
LOWcopyedit
Standardise the formatting of confidence intervals throughout: use en dash or 'to' consistently (e.g., '0.96 to 5.82' in text, ensure tables match).
Minor formatting consistency improves readability and avoids copyeditor queries.
9.
LOWcopyedit
In Table 2 and Table 4, standardise the display of subscale names (e.g., remove extra colon in 'KOOS-4: (0-100):').
Minor formatting issue that can be caught with a final proofread.
10.
LOWcopyedit
In Table 1 footnote, clarify whether the reported intraclass correlation coefficient (0.94, 95% CI 0.90 to 0.96) refers to intra-rater or inter-rater reliability, as the model described ('two-way random effects model with absolute agreement') is typically used for inter-rater reliability.
Resolves a potential confusion for readers about the type of reliability assessed.
11.
LOWreporting
Consider providing the brace adherence data as a supplementary dataset with a DOI to enhance the reproducibility of the complier average causal effect (CACE) analysis.
Would strengthen the transparency and reusability of the trial data.

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