Summary
This review applies the Geng six-style forensic framework to Derdeyn et al.'s 2013 Neurosurgery paper (DOI: 10.1227/NEU.0b013e318286fdc8) on stroke mechanisms in the SAMMPRIS trial. Overall verdict: questionable (yellow). One substantive issue was identified: a logical data inconsistency in Table 3 involving Patient 25, a 76-year-old female recorded with a 30-day mRS score of 5 in one column while another column states the patient died 3 days after the procedure. Since death corresponds to mRS 6, this is a clear internal contradiction in clinical trial record-keeping. The arithmetic and statistical checks (33/224 = 14.7% symptomatic stroke rate; 220 minus 6 aborted minus 1 failed crossing = 213) were internally consistent. The device timeline (Wingspan FDA approval 2005; trial 2011; submission 2012; publication 2013) was also consistent. Image-based forensics could not be performed because the provided PDF text did not include raw pixel data for Figures 1 and 2. Confidence is moderate; the single finding is more likely a data-entry error than deliberate manipulation, but it warrants verification against the original case report form.
Verdict
Questionable (yellow). One internal logical conflict in clinical data was identified; arithmetic and timeline checks passed; image forensics were not feasible with the supplied source.
Key findings
- Internal data conflict in Table 3 (Patient 25): A 76-year-old female is assigned a 30-day mRS of 5 in one column, while a neighboring column records "Died 3 days after procedure." Per the modified Rankin Scale, death is scored as 6, making this a direct logical contradiction.
- Arithmetic consistency: 33/224 = 0.14732, rounds to 14.7%, matching the reported 30-day symptomatic stroke rate. The flow 220 attempted − 6 aborted − 1 failed crossing = 213 is internally consistent.
- Device timeline consistency: Gateway PTA Balloon Catheter and Wingspan Stent System were FDA-approved in 2005; SAMMPRIS preliminary results were announced in 2011; the manuscript was submitted in September 2012 and published in 2013. No anachronism detected.
- Image-forensic limitations: Figures 1 and 2 could not be analyzed for duplication, splicing, or noise anomalies because the source PDF provided only textual descriptions and captions, not pixel data.
Evidence highlights
- Patient 25, Table 3: 30-day mRS = 5; "Family withdrew care. Died 3 days after procedure." (DOI: 10.1227/NEU.0b013e318286fdc8)
- Statistical check: 33 ÷ 224 = 0.14732 ≈ 14.7% (Results, pp. 777–778).
- Patient flow arithmetic: 220 − 6 − 1 = 213 (Patients and Methods, p. 778).
- Device chronology: Wingspan FDA approval 2005; trial result 2011; submission September 2012; publication 2013.
Notes
- The most plausible explanation is a data-entry oversight in the case report form, not deliberate under-reporting of mortality. Nevertheless, the contradiction should be reconciled against the original CRF and, if confirmed as an error, corrected via an erratum to the journal.
- No evidence of image manipulation could be established; absence of pixel-level analysis means duplication or splicing cannot be ruled out.
- All arithmetic and chronological checks were internally self-consistent.
- This report is AI-assisted and intended for academic discussion; final determination of misconduct requires institutional investigation.
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