• Injury · Nov 2024

    An endpoint adjudication committee for the assessment of computed tomography scans in fracture healing.

    • Chloe Elliott, Ethan D Patterson, Adina Tarcea, Brenna Mattiello, Bevan Frizzell, Richard E A Walker, Kevin A Hildebrand, and Neil J White.
    • University of Calgary, Cumming School of Medicine, 2500 University Dr NW, Calgary, AB T2N 1N4, Canada.
    • Injury. 2024 Nov 26; 56 (2): 112067112067.

    IntroductionEndpoint Adjudication Committees (EACs) benefit the quality of randomized control trials (RCTs) where outcomes depend on subjective interpretations. However, assembling a committee to adjudicate large datasets is cumbersome. In a recent RCT, the primary outcome was time to union following operative fixation of scaphoid non-union, with real or placebo adjunctive ultrasound treatment. Union status was determined with computed tomography (CT) scans interpreted by treating surgeons and radiologists. An EAC was established to deliberate discrepancies between radiologists' and surgeons' interpretations of union status.MethodsThree hundred sixty-four CT scans from 142 participants were collected in the RCT. The treating surgeon and an MSK radiologist categorized images by percent-union (0 %, 1-24 %, 25-49 %, 50-74 %, 75-99 %, 100 %). Union was defined as at least 50 % trabecular bridging. The EAC adjudicated those images that were deemed major discrepancies. The committee was composed of three members assembled by the committee chair, an MSK radiologist. A charter was established to guide the adjudication process. Ten minutes were allotted to each scan, including 2-3 min of an independent adjudicator's review, followed by 5-7 min of committee discussion to reach a diagnosis.ResultsAdjudicators spent an average of seven minutes on each scan. The EAC assessed 101 CT scans from 69 patients collected across five study sites: four scans from the agreed upon group as practice interpretations, 75 major discrepancies, and 22 missing interpretations from either the initial MSK radiologist, the treating orthopaedic surgeon, or both. These were adjudicated for final union status. Twenty-eight of the images with major discrepancies were adjudicated to union, and 47 to non-union. Adjudication changed the primary outcome of time to union in 40/142 (28 %) of study participants.ConclusionThis adjudication process provides a valuable research tool for reference by other clinical investigators whose RCTs' outcomes are dependent on interpretation of radiographic images.Copyright © 2024. Published by Elsevier Ltd.

      Pubmed     Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…