Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology: Interim Analysis for Enthesitis
Bibliographic record
Abstract
Objectives Ultrasonography (US) has experienced a rapid evolution in rheumatology. Despite many advantages being repeatedly shown, several barriers persist, equipment cost being an important one. Handheld US technology promises to substantially lower this cost. However, before it can be used explicitly for rheumatology, its performance must be validated against gold-standard devices. We aim to test the concurrent validity of a handheld US device versus a gold-standard device to detect characteristic features of enthesitis. Methods PsA patients with at least 1 tender and swollen joint were included. Each patient had consecutive US examinations using a handheld (Clarius Mobile Health Inc, HD3 L15 scanner) and a gold-standard US device (GE LogicE9) for detecting elementary lesions of enthesitis. Supraspinatus, triceps, common extensor tendon, quadriceps, patellar ligament, Achilles tendon and plantar fascia entheses were evaluated. B-mode and power Doppler images were saved for each site and lesion. Every image was given a unique identifier number after collection for blinding purpose. Image reading was performed at least 2 weeks after the acquisition of US in all patients, using a random order slide show, irrespective of the machine, anatomical site or patient, to ensure blindness. The inflammation score was obtained by summing hypoechogenicity, thickening, and Doppler scores, and the chronicity score was obtained by summing erosion, enthesophyte, and calcification scores. Cohen’s kappa coefficient was calculated to test the agreement for elementary lesions of enthesitis, in addition to intraclass correlation analysis. Here we present interim analysis for the first 10 patients to detect enthesitis in 160 entheses. Results On the day of the US, 8 (80%) patients had at least 1 tender enthesis on physical examination. The median (IQR) SPARCC enthesitis score was 3 (0.75-5.0). The agreement was substantial (see Table) for enthesophytes and erosions; moderate for thickening, Doppler and hypoechogenicity; and slight for calcification (Table). A very strong agreement was detected between the devices both for the inflammation and chronicity scores (ICC (intraclass correlation) and p values: inflammation: 0.957 and <0.001; chronicity: 0.934 and <0.001). Table: The frequency, kappa and percent absolute agreement of elementary lesions in enthesitis areas Conclusion In this interim analysis, the handheld US device with L15 scanner showed moderate-substantial agreement to detect elementary lesions of enthesitis, with the exception of calcifications. In addition, a very strong consistency was found between the devices in inflammation, chronicity and total enthesitis scores, which enable physicians to evaluate enthesitis as a whole. These interim results encourage testing the use of handheld US devices for wider use.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.048 | 0.094 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".