Dataset Information

Exploring the Villalta scale to capture postthrombotic syndrome using alternative approaches: A subanalysis of the ATTRACT trial.

ABSTRACT:

Background

Clinical trials that evaluated interventions to prevent postthrombotic syndrome (PTS) used the Villalta scale (VS) to define PTS, but there is a lack of consistency in its use.

Objectives

This study aimed to improve the ability to identify patients with clinically meaningful PTS after DVT in participants of the ATTRACT trial.

Methods

We conducted a post hoc exploratory analysis of 691 patients from the ATTRACT study, a randomized trial evaluating the effectiveness of pharmacomechanical thrombolysis to prevent PTS in proximal deep vein thrombosis. We compared 8 VS approaches to classify patients with or without PTS in terms of their ability to discriminate between those with poorer vs better venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL]) between 6- and 24-months follow-up. The difference in the average area under the fitted curve of VEINES-QOL scores between PTS and no PTS ( ΔAUC¯ ) were compared among approaches.

Results

For any PTS (a single VS score ≥5), approaches 1 to 3 had similar ΔAUC¯ (-21.2, -23.7, -22.0, respectively). Adjusting the VS for contralateral chronic venous insufficiency (CVI) or restricting to patients without baseline CVI (approaches 7 and 8) did not improve ΔAUC¯ (-13.6, -19.9, respectively; P >.01). For moderate-to-severe PTS (a single VS score ≥10), approaches 5 and 6 requiring 2 positive assessments had greater but not statistically significant ΔAUC¯ than approach 4, using one single positive assessment (-31.7, -31.0, -25.5, respectively; P >.01).

Conclusion

A single VS score of ≥ 5 reliably distinguishes patients with clinically meaningful PTS as assessed by impact on QOL and is preferred because of greater convenience (only one assessment needed). Alternative methods to define PTS (ie, adjusting for CVI) do not improve the scale's ability to identify clinically meaningful PTS.

SUBMITTER: Pop CT

PROVIDER: S-EPMC10031339 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Exploring the Villalta scale to capture postthrombotic syndrome using alternative approaches: A subanalysis of the ATTRACT trial.

Pop Cristina T CT Gu Chu-Shu CS Vedantham Suresh S Galanaud Jean-Philippe JP Kahn Susan R SR

Research and practice in thrombosis and haemostasis 20221227 1

<h4>Background</h4>Clinical trials that evaluated interventions to prevent postthrombotic syndrome (PTS) used the Villalta scale (VS) to define PTS, but there is a lack of consistency in its use.<h4>Objectives</h4>This study aimed to improve the ability to identify patients with clinically meaningful PTS after DVT in participants of the ATTRACT trial.<h4>Methods</h4>We conducted a post hoc exploratory analysis of 691 patients from the ATTRACT study, a randomized trial evaluating the effectivenes ...[more]

PMID: 36970743

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Project description:BackgroundImprovements in data processing, increased understanding of the biomechanical background behind kinetics and kinematics, and technological advancements in inertial measurement unit (IMU) sensors have enabled high precision in the measurement of joint angles and acceleration on human subjects. This has resulted in new devices that reportedly measure joint angles, arm speed, and stresses to the pitching arms of baseball players. This study seeks to validate one such sensor, the MotusBASEBALL unit, with a marker-based motion capture laboratory.HypothesisWe hypothesize that the joint angle measurements ("arm slot" and "shoulder rotation") of the MotusBASEBALL device will hold a statistically significant level of reliability and accuracy, but that the "arm speed" and "stress" metrics will not be accurate due to limitations in IMU technology.MethodsA total of 10 healthy subjects threw five to seven fastballs followed by five to seven breaking pitches (slider or curveball) in the motion capture lab. Subjects wore retroreflective markers and the MotusBASEBALL sensor simultaneously.ResultsIt was found that the arm slot (R = 0.975, P < 0.001), shoulder rotation (R = 0.749, P < 0.001), and stress (R = 0.667, P = 0.001 when compared to elbow torque; R = 0.653, P = 0.002 when compared to shoulder torque) measurements were all significantly correlated with the results from the motion capture lab. Arm speed showed significant correlations to shoulder internal rotation speed (R = 0.668, P = 0.001) and shoulder velocity magnitude (R = 0.659, P = 0.002). For the entire sample, arm slot and shoulder rotation measurements were on a similar scale, or within 5-15% in absolute value, of magnitude to measurements from the motion capture test, averaging eight degrees less (12.9% relative differences) and nine degrees (5.4%) less, respectively. Arm speed had a much larger difference, averaging 3,745 deg/s (80.2%) lower than shoulder internal rotation velocity, and 3,891 deg/s (80.8%) less than the shoulder velocity magnitude. The stress metric was found to be 41 Newton meter (Nm; 38.7%) less when compared to elbow torque, and 42 Nm (39.3%) less when compared to shoulder torque. Despite the differences in magnitude, the correlations were extremely strong, indicating that the MotusBASEBALL sensor had high reliability for casual use.ConclusionThis study attempts to validate the use of the MotusBASEBALL for future studies that look at the arm slot, shoulder rotation, arm speed, and stress measurements from the MotusBASEBALL sensor. Excepting elbow extension velocity, all metrics from the MotusBASEBALL unit showed significant correlations to their corresponding metrics from motion capture and while some magnitudes differ substantially and therefore fall short in validity, the link between the metrics is strong enough to indicate reliable casual use. Further research should be done to further investigate the validity and reliability of the arm speed metric.

Dataset Information

Exploring the Villalta scale to capture postthrombotic syndrome using alternative approaches: A subanalysis of the ATTRACT trial.

Background

Objectives

Methods

Results

Conclusion

Publications

Exploring the Villalta scale to capture postthrombotic syndrome using alternative approaches: A subanalysis of the ATTRACT trial.

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