Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.

Name: Kaimen Rigor review — Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.
Item: Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.
Rating: 100
Author: Alpha1

Kanto K, Bäck M, Ibounig T, Björkenheim R, Malmivaara A, Czuba T, Inkinen J, Kalske J, Savolainen V, Sinisaari I, Toivonen P, Taimela S, Järvinen TLN, Paavola M, Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators

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Kaimen Rigor review — 2.5★ (Weak), 0 critical, 3 high issues for “Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.

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DOI

10.1136/bmj-2025-086201

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.

Paper source

Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.5 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsOverstated claim−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★

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

Not verified in this report

Statistics were not checked: no recomputable values were found in this text — no test statistic reported with its degrees of freedom, no effect estimate printed with both a 95% CI and a p-value, and no percentage printed with both its count and its denominator.
The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 24 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.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcomes are patient-reported pain scores (VAS) at rest and on arm activity, which are subjective symptom measures rather than hard clinical outcomes. The paper does not demonstrate target engagement at the tested dose or cite validated evidence linking these surrogate measures to a hard clinical outcome. The minimal important difference (MID) of 15 points is defined, but the link to clinical meaningfulness is not validated.
“The primary outcomes were shoulder pain at rest and on arm activity, both assessed at 10 years using a visual analogue scale (VAS, ranging from 0 to 100, with 0 denoting no pain). The minimally important difference was defined as 15.”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary comparison (ASD vs placebo surgery) showed no significant difference, with mean differences of -1.5 points (95% CI -8.6 to 5.6) for pain at rest and -3.2 points (-13.0 to 6.5) for pain on arm activity. These differences are far below the predefined MID of 15 points, indicating no clinically meaningful effect. The paper concludes no benefit, but the effect sizes are not anchored to clinical meaningfulness beyond the MID.
“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest and −3.2 points (−13.0 to 6.5) in VAS pain score on arm activity.”
Find in source
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
ASD should not be offered outside clinical trials.
“Based on current evidence, ASD should not be offered outside rigorously designed clinical trials.”
ConclusionFind in source
04Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT00428870 was first submitted to ClinicalTrials.gov on 2007-01-29, after the registered study start date of 2005-02. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT00428870
reviewer’s wording

Findings by category

101ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 103AuthenticityData authenticity concerns 04DisclosureNone found 05AvailabilityNone found 06Copyedit3 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 rigorously designed and transparently reported randomized placebo-surgery-controlled trial with 10-year follow-up. The paper demonstrates strong methodology across all eight dimensions, with minor reporting gaps (outlier handling, retrospective registration) and a small arithmetic inconsistency in the abstract.

Both reviewers independently scored all dimensions as pass, with only minor divergence on outlier handling (one rated it inadequate). The study type is interventional, agreed by both. Non-applicable criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification could not recompute any tests due to limited coverage, so statistical correctness is not fully confirmed.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

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 overstated beyond the evidenceAssessed

3 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

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

Data authenticity concerns

1 finding · worst medium

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.

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

None found

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.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites eight RCTs and a Cochrane review, acknowledging the consistency of short-term null results and the lack of long-term data. The rationale for the trial is clearly linked to the gap in long-term evidence. Limitations of prior work (e.g., short follow-up, open-label designs) are implicitly addressed by the trial's design and placebo control.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior RCTs and systematic reviews showing no short-term benefit of ASD, and justifies the need for long-term follow-up.

Evidence

“Yet eight randomised controlled trials have shown with notable consistency that ASD provides no short term (12 to 24 months) or medium term (≤5 years) advantage over placebo surgery or non-surgical management”

Introduction ¶1Find in source

“We conducted a multicentre, randomised, placebo surgery controlled trial to evaluate the long term (10 year) efficacy of ASD compared with placebo surgery”

Introduction ¶2Find in source

“Our efficacy design, with a placebo surgery comparator and high participant retention (87%), strengthens the reliability of the effect estimates”

Discussion ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior RCTs and systematic reviews showing no short/medium-term benefit of ASD, and justifies the need for long-term data.

Evidence

Introduction ¶1Find in source

“We conducted a multicentre, randomised, placebo surgery controlled trial to evaluate the long term (10 year) efficacy of ASD compared with placebo surgery”

Introduction ¶2Find in source

“Both CSAW and FIMPACT showed no meaningful benefit of ASD over placebo surgery for pain or functional outcomes in the short term (one year for CSAW, two and five years for FIMPACT ), a result now confirmed by FIMPACT’s 10 year follow-up as well.”

Discussion ¶1Find in source

Randomization used sequentially numbered sealed opaque envelopes with varied block sizes, and participants and outcome assessors were blinded. A priori power analysis (n=204, 90% power) was reported. Inclusion/exclusion criteria were detailed. Outlier handling is addressed via the pre-specified analysis population (ITT, per-protocol, as-treated) and mixed model handling of missing data. Controls are inherent in the placebo surgery arm. 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 is rigorously designed with proper randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

“Randomisation was carried out using sequentially numbered sealed opaque envelopes. A statistician with no involvement in the clinical care of trial participants prepared separate randomisation lists for each centre using varied block size.”

MethodsFind in source

“The participants in the two primary study groups (ASD and placebo surgery) as well as individuals who collected the data were unaware of the study group assignments.”

MethodsFind in source

“We calculated that a sample size of 204 participants (68 per arm; two sided α=0.05, β=90%) would be needed to detect a difference of at least the MID (15 points)”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial is rigorously designed with proper randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Participants and outcome assessors were blinded to group allocation in the primary (ASD versus placebo surgery) comparison.”

AbstractFind in source

“We calculated that a sample size of 204 participants (68 per arm; two sided α=0.05, β=90%) would be needed to detect a difference of at least the MID (15 points)”

Statistical analysisFind in source

Sex and age are reported in Table 1. Health status is addressed through inclusion/exclusion criteria (e.g., no full-thickness rotator cuff tear, no osteoarthritis). Demographics include age, sex, and some functional status. Species/strain and housing 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

Human demographics (age, sex) are reported in baseline table; health status is implied by inclusion criteria.

Evidence

“Age (years) | 50.5 (7.3) | 50.8 (7.6) | 50.4 (6.6) | | No (%) women | 42 (71) | 46 (73) | 47 (66)”

Table 1Find in source

“Participants were considered eligible for the study if they were men or women aged 35-65 years, had experienced subacromial pain for longer than three months”

MethodsFind in source

PASSReviewer 2· 90% conf

Demographic and baseline clinical characteristics are well reported, including age, sex, and health status.

Evidence

“Age (years) | 50.5 (7.3) | 50.8 (7.6) | 50.4 (6.6) | | No (%) women | 42 (71) | 46 (73) | 47 (66)”

Table 1Find in source

“VAS score at rest* | 41.3 (25.8) | 41.6 (25.5) | 41.7 (27.5)”

Table 1Find in source

The study was approved by the institutional review board of the Pirkanmaa Hospital District (R04200). Written informed consent was obtained from all participants. The trial was conducted in accordance with the Declaration of Helsinki.

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 from a named IRB and informed consent are reported; compliance with Declaration of Helsinki is stated.

Evidence

paraphrase[Ethics statements]

“This study was approved by the institutional review board of the Pirkanmaa Hospital District ( R04200 ; 28 December 2004).”

“All participants gave written informed consent.”

MethodsFind in source

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

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named IRB and informed consent are clearly documented, along with compliance with the Declaration of Helsinki.

Evidence

paraphrase[Ethics statements]

“This study was approved by the institutional review board of the Pirkanmaa Hospital District ( R04200 ; 28 December 2004).”

“All participants gave written informed consent.”

MethodsFind in source

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

EthicsFind in source

The surgical procedures (ASD and placebo) are described in detail, including the equipment (4 mm arthroscope) and technique. No antibodies, cell lines, or reagents are used. Statistical software (Stata 18) is identified. The trial is scored because the surgical intervention is the key resource.

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 (ASD procedure) is described in detail; no other key biological/chemical resources are used.

Evidence

“we continued the surgery by performing a standard ASD procedure—a subacromial bursectomy and resection of bony spurs and the projecting anterolateral undersurface of the acromion with a shaver, burr, or electrocoagulation, or combination.”

MethodsFind in source

“Stata version 18 (StataCorp, TX) was used for all statistical analyses.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (ASD procedure) is described in detail, and statistical software is identified.

Evidence

“We carried out arthroscopic examination of the glenohumeral joint and subacromial space and assessed rotator cuff integrity using standard posterior and lateral portals and a 4 mm arthroscope”

MethodsFind in source

“Stata version 18 (StataCorp, TX) was used for all statistical analyses.”

Statistical analysisFind in source

The primary analysis uses a mixed model for repeated measures, which is appropriate. Effect sizes are reported with 95% CIs, and p-values are not the primary focus (estimation-based reporting). Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks were not applicable due to continuous outcomes and model-based estimates.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

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-described; effect sizes with CIs are reported; no arithmetic errors detected.

Evidence

“A mixed model for repeated measurements analysis of variance was used with participant as a random factor (time points: three, six, 12, and 24 months, and five and 10 years), the baseline value as a covariate, and identity covariance as the covariance structure.”

Statistical analysisFind in source

“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with effect sizes and confidence intervals reported; p-values are not the primary focus.

Evidence

Statistical analysisFind in source

“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest”

AbstractFind in source

The data availability statement provides a DOI for the dataset and states that code is in supplemental files. This is a concrete access route, satisfying the criterion. Repository deposit and accession numbers are covered by the DOI. Code sharing is via supplemental files, which is acceptable.

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are openly available with a DOI; data availability statement is concrete.

Evidence

“The data underlying the findings in this paper are openly and publicly available at https://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74”

Data availabilityFind in source

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

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are openly available with a DOI, and the data availability statement is concrete.

Evidence

“The data underlying the findings in this paper are openly and publicly available at https://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74”

Data availabilityFind in source

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

Data availabilityFind in source

Trial registration number is provided (NCT00428870). CONSORT guidelines are followed. All pre-specified outcomes are reported, including null results. Limitations are discussed in the discussion and supplementary table S8. Conclusions are proportional to the evidence. Funding sources and COI 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 trial is registered, follows CONSORT, reports all outcomes, discusses limitations, and provides funding/COI statements.

Evidence

“ClinicalTrials.gov NCT00428870”

AbstractFind in source

“Reporting follows the consolidated standards of reporting trials (CONSORT) guidelines.”

MethodsFind in source

“The FIMPACT trial was supported by the Sigrid Juselius Foundation, State Research Funding for university level health research (Tampere and Helsinki University Hospitals), Academy of Finland, and Jane and Aatos Erkko Foundation.”

FundingFind in source

PASSReviewer 2· 95% conf

The trial is registered, follows CONSORT, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov NCT00428870”

AbstractFind in source

“Reporting follows the consolidated standards of reporting trials (CONSORT) guidelines.”

MethodsFind in source

FundingFind in source

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

Broken references and links

None found

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

Checked — nothing surfaced.

Checked 27 references by DOI: 25 verified — 2 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

3 minor

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

No major wording or formatting errors. 3 minor suggestions below.

3 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is methodologically robust and transparent, with minor reporting gaps that an informed reader should weigh: the abstract's 87% completion figure appears inconsistent with the numbers (168/210=80%), and trial registration was retrospective. These do not undermine the core findings but warrant clarification or an erratum.

1.
HIGHcopyedit
In the Abstract (Results), correct the percentage for participants completing 10-year follow-up: 168/210 = 80%, not 87%. Verify the denominator and adjust the text or provide the correct denominator.
The stated 87% is arithmetically inconsistent with the reported numbers (168/210), which could mislead readers and reviewers.
2.
HIGHreporting
In the Methods (Enrolment and randomisation), add a statement on how outliers were handled, e.g., whether any were identified and whether sensitivity analyses excluding them were performed.
One reviewer flagged outlier handling as inadequate; explicit reporting would fully address the criterion.
3.
HIGHreporting
In the Discussion or a footnote, acknowledge that trial registration (NCT00428870) was retrospective (first submitted 2007-01-29, after the study start date of 2005-02) and discuss any implications for transparency.
Retrospective registration is a transparency concern that readers should be aware of; acknowledging it strengthens the paper's integrity.
4.
MEDIUMcopyedit
In the Methods (Enrolment and randomisation), fix the article error: change 'and a alcohol dependency' to 'and an alcohol dependency'.
Minor typo that should be corrected for professional presentation.
5.
MEDIUMreporting
In the Discussion, temper the claim that 'ASD should not be offered outside clinical trials' to reflect that this is a policy recommendation extending beyond the trial's direct findings, or add supporting evidence.
The claim audit flagged this as overstated; aligning the conclusion with the evidence avoids over-claiming.
6.
MEDIUMdata code
Consider depositing the statistical analysis code in a public repository (e.g., GitHub) with a versioned DOI, in addition to supplemental files.
Enhances reproducibility and discoverability beyond supplemental files.
7.
MEDIUMreporting
Add a statement in the Methods or supplement on whether any post-hoc analyses were performed and how they were flagged.
Transparency about post-hoc analyses helps readers interpret exploratory findings.
8.
MEDIUMreporting
Add a note in the Methods on the handling of multiple comparisons for secondary outcomes, even if exploratory.
Clarifies the risk of type I errors in secondary analyses.
9.
LOWreporting
Consider reporting exact p-values for secondary outcomes in supplementary tables to facilitate meta-analyses.
While estimation-based reporting is acceptable, exact p-values aid future syntheses.
10.
LOWreporting
Add a statement on the generalizability of findings to other healthcare settings, given the single-country setting.
Helps readers assess external validity.
11.
LOWreporting
Add a patient and public involvement statement in the main text, if not already present.
Enhances transparency about patient engagement.

Full text (40,322 chars)Analyzed: Aug 15, 2026

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Read alongside

Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.

Read full text (PMC)

DOI

10.1136/bmj-2025-086201

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Record fingerprint

47d9c663742279f6f39edb2f531781058604021d6243b45612b4f482baeb9dde

Verify via API

Issued Aug 15, 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 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsOverstated claim−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★

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

Not verified in this report

Statistics were not checked: no recomputable values were found in this text — no test statistic reported with its degrees of freedom, no effect estimate printed with both a 95% CI and a p-value, and no percentage printed with both its count and its denominator.
The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 24 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.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcomes are patient-reported pain scores (VAS) at rest and on arm activity, which are subjective symptom measures rather than hard clinical outcomes. The paper does not demonstrate target engagement at the tested dose or cite validated evidence linking these surrogate measures to a hard clinical outcome. The minimal important difference (MID) of 15 points is defined, but the link to clinical meaningfulness is not validated.
“The primary outcomes were shoulder pain at rest and on arm activity, both assessed at 10 years using a visual analogue scale (VAS, ranging from 0 to 100, with 0 denoting no pain). The minimally important difference was defined as 15.”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary comparison (ASD vs placebo surgery) showed no significant difference, with mean differences of -1.5 points (95% CI -8.6 to 5.6) for pain at rest and -3.2 points (-13.0 to 6.5) for pain on arm activity. These differences are far below the predefined MID of 15 points, indicating no clinically meaningful effect. The paper concludes no benefit, but the effect sizes are not anchored to clinical meaningfulness beyond the MID.
“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest and −3.2 points (−13.0 to 6.5) in VAS pain score on arm activity.”
Find in source
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
ASD should not be offered outside clinical trials.
“Based on current evidence, ASD should not be offered outside rigorously designed clinical trials.”
ConclusionFind in source
04Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT00428870 was first submitted to ClinicalTrials.gov on 2007-01-29, after the registered study start date of 2005-02. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT00428870
reviewer’s wording

Findings by category

101ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 103AuthenticityData authenticity concerns 04DisclosureNone found 05AvailabilityNone found 06Copyedit3 minor suggestions

Numerical inconsistencies

1 finding · worst low

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 overstated beyond the evidenceAssessed

3 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

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

Data authenticity concerns

1 finding · worst medium

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior RCTs and systematic reviews showing no short-term benefit of ASD, and justifies the need for long-term follow-up.

Evidence

Introduction ¶1Find in source

“We conducted a multicentre, randomised, placebo surgery controlled trial to evaluate the long term (10 year) efficacy of ASD compared with placebo surgery”

Introduction ¶2Find in source

“Our efficacy design, with a placebo surgery comparator and high participant retention (87%), strengthens the reliability of the effect estimates”

Discussion ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior RCTs and systematic reviews showing no short/medium-term benefit of ASD, and justifies the need for long-term data.

Evidence

Introduction ¶1Find in source

“We conducted a multicentre, randomised, placebo surgery controlled trial to evaluate the long term (10 year) efficacy of ASD compared with placebo surgery”

Introduction ¶2Find in source

Discussion ¶1Find 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 is rigorously designed with proper randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“The participants in the two primary study groups (ASD and placebo surgery) as well as individuals who collected the data were unaware of the study group assignments.”

MethodsFind in source

“We calculated that a sample size of 204 participants (68 per arm; two sided α=0.05, β=90%) would be needed to detect a difference of at least the MID (15 points)”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial is rigorously designed with proper randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Participants and outcome assessors were blinded to group allocation in the primary (ASD versus placebo surgery) comparison.”

AbstractFind in source

“We calculated that a sample size of 204 participants (68 per arm; two sided α=0.05, β=90%) would be needed to detect a difference of at least the MID (15 points)”

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Human demographics (age, sex) are reported in baseline table; health status is implied by inclusion criteria.

Evidence

“Age (years) | 50.5 (7.3) | 50.8 (7.6) | 50.4 (6.6) | | No (%) women | 42 (71) | 46 (73) | 47 (66)”

Table 1Find in source

“Participants were considered eligible for the study if they were men or women aged 35-65 years, had experienced subacromial pain for longer than three months”

MethodsFind in source

PASSReviewer 2· 90% conf

Demographic and baseline clinical characteristics are well reported, including age, sex, and health status.

Evidence

“Age (years) | 50.5 (7.3) | 50.8 (7.6) | 50.4 (6.6) | | No (%) women | 42 (71) | 46 (73) | 47 (66)”

Table 1Find in source

“VAS score at rest* | 41.3 (25.8) | 41.6 (25.5) | 41.7 (27.5)”

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 from a named IRB and informed consent are reported; compliance with Declaration of Helsinki is stated.

Evidence

paraphrase[Ethics statements]

“This study was approved by the institutional review board of the Pirkanmaa Hospital District ( R04200 ; 28 December 2004).”

“All participants gave written informed consent.”

MethodsFind in source

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

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named IRB and informed consent are clearly documented, along with compliance with the Declaration of Helsinki.

Evidence

paraphrase[Ethics statements]

“This study was approved by the institutional review board of the Pirkanmaa Hospital District ( R04200 ; 28 December 2004).”

“All participants gave written informed consent.”

MethodsFind in source

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

EthicsFind 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 (ASD procedure) is described in detail; no other key biological/chemical resources are used.

Evidence

MethodsFind in source

“Stata version 18 (StataCorp, TX) was used for all statistical analyses.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (ASD procedure) is described in detail, and statistical software is identified.

Evidence

“We carried out arthroscopic examination of the glenohumeral joint and subacromial space and assessed rotator cuff integrity using standard posterior and lateral portals and a 4 mm arthroscope”

MethodsFind in source

“Stata version 18 (StataCorp, TX) was used for all statistical analyses.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

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-described; effect sizes with CIs are reported; no arithmetic errors detected.

Evidence

Statistical analysisFind in source

“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with effect sizes and confidence intervals reported; p-values are not the primary focus.

Evidence

Statistical analysisFind in source

“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest”

AbstractFind in source

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are openly available with a DOI; data availability statement is concrete.

Evidence

“The data underlying the findings in this paper are openly and publicly available at https://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74”

Data availabilityFind in source

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

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are openly available with a DOI, and the data availability statement is concrete.

Evidence

“The data underlying the findings in this paper are openly and publicly available at https://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74”

Data availabilityFind in source

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

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 trial is registered, follows CONSORT, reports all outcomes, discusses limitations, and provides funding/COI statements.

Evidence

“ClinicalTrials.gov NCT00428870”

AbstractFind in source

“Reporting follows the consolidated standards of reporting trials (CONSORT) guidelines.”

MethodsFind in source

FundingFind in source

PASSReviewer 2· 95% conf

The trial is registered, follows CONSORT, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov NCT00428870”

AbstractFind in source

“Reporting follows the consolidated standards of reporting trials (CONSORT) guidelines.”

MethodsFind in source

FundingFind in source

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

Broken references and links

None found

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

Checked — nothing surfaced.

Checked 27 references by DOI: 25 verified — 2 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

3 minor

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

No major wording or formatting errors. 3 minor suggestions below.

3 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHcopyedit
In the Abstract (Results), correct the percentage for participants completing 10-year follow-up: 168/210 = 80%, not 87%. Verify the denominator and adjust the text or provide the correct denominator.
The stated 87% is arithmetically inconsistent with the reported numbers (168/210), which could mislead readers and reviewers.
2.
HIGHreporting
In the Methods (Enrolment and randomisation), add a statement on how outliers were handled, e.g., whether any were identified and whether sensitivity analyses excluding them were performed.
One reviewer flagged outlier handling as inadequate; explicit reporting would fully address the criterion.
3.
HIGHreporting
In the Discussion or a footnote, acknowledge that trial registration (NCT00428870) was retrospective (first submitted 2007-01-29, after the study start date of 2005-02) and discuss any implications for transparency.
Retrospective registration is a transparency concern that readers should be aware of; acknowledging it strengthens the paper's integrity.
4.
MEDIUMcopyedit
In the Methods (Enrolment and randomisation), fix the article error: change 'and a alcohol dependency' to 'and an alcohol dependency'.
Minor typo that should be corrected for professional presentation.
5.
MEDIUMreporting
In the Discussion, temper the claim that 'ASD should not be offered outside clinical trials' to reflect that this is a policy recommendation extending beyond the trial's direct findings, or add supporting evidence.
The claim audit flagged this as overstated; aligning the conclusion with the evidence avoids over-claiming.
6.
MEDIUMdata code
Consider depositing the statistical analysis code in a public repository (e.g., GitHub) with a versioned DOI, in addition to supplemental files.
Enhances reproducibility and discoverability beyond supplemental files.
7.
MEDIUMreporting
Add a statement in the Methods or supplement on whether any post-hoc analyses were performed and how they were flagged.
Transparency about post-hoc analyses helps readers interpret exploratory findings.
8.
MEDIUMreporting
Add a note in the Methods on the handling of multiple comparisons for secondary outcomes, even if exploratory.
Clarifies the risk of type I errors in secondary analyses.
9.
LOWreporting
Consider reporting exact p-values for secondary outcomes in supplementary tables to facilitate meta-analyses.
While estimation-based reporting is acceptable, exact p-values aid future syntheses.
10.
LOWreporting
Add a statement on the generalizability of findings to other healthcare settings, given the single-country setting.
Helps readers assess external validity.
11.
LOWreporting
Add a patient and public involvement statement in the main text, if not already present.
Enhances transparency about patient engagement.

Full text (40,322 chars)Analyzed: Aug 15, 2026