Evaluation of a VENOus-Return Assist Device (Venowave™) To Treat Severe Post-Thrombotic Syndrome (VENOPTS): A Randomized Controlled Trial.
Bibliographic record
Abstract
Abstract Severe post-thrombotic syndrome (PTS) is responsible for considerable disability, reduced quality of life and increased health care costs. Current therapies are limited and often ineffective. Methods: We performed a two-center, randomized, cross-over controlled trial to evaluate Venowave™, a novel lower-limb venous return assist device, for the treatment of severe PTS. Eligible subjects were allocated to receive, in randomized order, Venowave™ for 8 weeks and control-device for 8 weeks. Participants were crossed-over after a 4-week (wash-out) period. The primary outcome measure was a clinical success, defined as; 1) reported benefit from the device with; 2) moderate (or greater) improvement in symptoms of PTS; and 3) willingness to continue using the device long-term. Secondary outcome measures included venous disease-specific quality of life (QOL) (measured by VEINES-QOL questionnaire; higher scores indicate better QOL) and PTS severity (measured by the Villalta PTS scale; higher scores indicate more severe PTS). The study was registered with ClinicalTrials.gov (NCT00182208). Results: Thirty-two patients were enrolled. Of these, 26 (80%) were also using graduated compression stockings. Twenty-six participants completed both trial periods. The primary outcome measure occurred in 10 participants receiving Venowave and 4 participants receiving the control-device (P=0.1). Two participants reported a clinical success with both devices. Mean Villalta scale score at the end of treatment period was significantly lower for Venowave™ (12.2; SD 6.3) compared to control (15.0; SD 6.1). (P=0.004) Mean VEINES-QOL score at the end of treatment period was significantly greater for Venowave™ (52.5; SD 5.8) compared to control (50.2; SD 6.2). (P=0.004) Conclusions: Venowave ™ is a very promising new therapy for patients with severe PTS, which may be used alone or in combination with graduated compression stockings. In our study population of patients with severe PTS, refractory to standard therapies, almost one-third of patients reported clinical improvement with Venowave™.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
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".