External Validation of the Patient-Reported Villalta Scale for the Diagnosis of Postthrombotic Syndrome

Ng, Sara; Rodger, Marc; Kovacs, Michael J.; Shivakumar, S; Kahn, Susan R.; Pm, Sandset; Kearon, Clive; Mallick, Ranjeeta; Delluc, Aurélien

doi:10.1055/a-1738-1313

Cited by 5 publications

(6 citation statements)

References 11 publications

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“…Overall PTS score in the adult survivors was higher compared to the pediatric survivors (1 point/child, 1.6 points/adult). A VS ≥5 has been validated to distinguish clinical meaningful PTS in adults, 34,41 which explains why fewer adult survivors received a PTS diagnosis. Six pediatric survivors had collaterals (50%) (1 point), only three of these survivors had another symptom and ended up with two or three points.…”

Section: Discussionmentioning

confidence: 99%

Sequelae and post‐thrombotic syndrome after venous thromboembolism in acute lymphoblastic leukemia survivors treated on the NOPHO ALL2008 protocol

Dam,

Lynggaard,

Jónsson

et al. 2024

Pediatric Blood & Cancer

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The treatment of acute lymphoblastic leukemia (ALL) is frequently complicated by toxicity, including venous thromboembolism (VTE) affecting roughly 8% of patients. VTE can lead to post‐thrombotic syndrome (PTS), a group of signs and symptoms developed as a complication to deep venous thrombosis (DVT), imposing risk of permanent disability and reduced quality of life (QoL). PTS prevalence ranges from 0% to 70%, reflecting very heterogenous cohorts and assessment tools. We aimed to estimate sequelae, including PTS and QoL in children and adults (<45 years old) who had a DVT during ALL treatment. PTS and QoL scores were obtained through use of Villalta and Modified Villalta Scale, PedsQL, and Short Form‐36 questionnaires. The cohort comprised 20 children (<18 years) and seven adults (median age: 12.9 years, range: 2–44 years) at the time of DVT diagnosis. In total, 25 ALL survivors underwent PTS examination. The examination took place when survivors were 7–48 years (median age: 20.3 years, median follow‐up time 6.8 years). QoL was assessed correlating cases with three matching ALL survivors without VTE. Two adults (15.4%) showed mild or moderate PTS. Eight children (66.7%) were diagnosed with mild PTS, while three cases had collaterals as sole symptoms. Pain or symptoms affecting daily life were reported by 16%. No difference in QoL was found (p = .9). This study underscores the need for comprehensive population‐based investigations with validation of PTS instruments in ALL survivors.

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Section: Discussionmentioning

confidence: 99%

Sequelae and post‐thrombotic syndrome after venous thromboembolism in acute lymphoblastic leukemia survivors treated on the NOPHO ALL2008 protocol

Dam,

Lynggaard,

Jónsson

et al. 2024

Pediatric Blood & Cancer

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“…Thus, the panel advocate for the Villalta scale to be used in conjunction with the three aforementioned diagnostic criteria. Ng et al (2022) recently validated the patient-reported Villalta scale (PRV) which may significantly reduce the burden on resources and clinical workload during patient followup [47]. The kappa value and agreement were 0.60 and 81%, respectively.…”

Section: Discussionmentioning

confidence: 99%

Epidemiology and Diagnosis of Post-Thrombotic Syndrome: Qualitative Synthesis with a Systematic Review

Mangwani,

Roberts,

Shannak

et al. 2023

JCM

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Background: Post-thrombotic syndrome (PTS) is a common and debilitating sequela of lower limb deep vein thrombosis (DVT). There is significant heterogeneity in reported PTS incidence due to lack of standardised diagnostic criteria. This review aimed to develop diagnostic criteria for PTS and subsequently refine the reported incidence and severity. Methods: PRISMA principles were followed; however, the review was not registered. The Cochrane CENTRAL database, MEDLINE, Embase, the NHS NICE Healthcare Databases Advanced Search interface, and trial registers including isrctn.com and clinicaltrials.gov were searched for studies addressing areas of interest (PTS definition, epidemiology, assessment). An experienced Clinical Librarian undertook the systematic searches, and two independent reviewers agreed on the relevance of the papers. Conflicts were resolved through panel review. Evidence quality was assessed using a modified Coleman scoring system and weighted according to their relevance to the aforementioned areas of interest. Results: A total of 339 abstracts were retrieved. A total of 33 full-text papers were included in this review. Following qualitative analysis, four criteria were proposed to define PTS: (1) a proven thrombotic event on radiological assessment; (2) a minimum 24-month follow-up period after an index DVT; (3) assessment with a validated score; and (4) evidence of progression of venous insufficiency from baseline. Four papers conformed to our PTS definition criteria, and the incidence of mild to moderate PTS ranged from 7 to 36%. On reviewing the studies which utilised the recommended Villalta scale, PTS incidence narrowed further to 23–36%. Incidence and severity reached a plateau at 24 months. Conclusions: Four diagnostic criteria were developed from qualitative synthesis. When these criteria were applied to the literature, the range of reported PTS incidence narrowed. These four criteria may standardise PTS diagnosis in future studies, facilitating the pooling of data for meta-analysis and synthesis of higher levels of evidence.

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“…76 Early validation studies show good correlations for patient-reported Villalta and Villalta scores when patients are provided a visual aid to support self-assessment. 77,78 Many QOL self-assessment measures can be completed remotely. However, in contemporary research on behavioral and neurological conditions, mobile technology–supported ecological momentary assessments are routinely used to enable more frequent and more convenient data capture from study participants.…”

Section: Efficacy Outcome Assessmentmentioning

confidence: 99%

Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction

Vedantham

Gloviczki

Carman

et al. 2023

Circ: Cardiovascular Interventions

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Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.

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External Validation of the Patient-Reported Villalta Scale for the Diagnosis of Postthrombotic Syndrome

Cited by 5 publications

References 11 publications

Sequelae and post‐thrombotic syndrome after venous thromboembolism in acute lymphoblastic leukemia survivors treated on the NOPHO ALL2008 protocol

Sequelae and post‐thrombotic syndrome after venous thromboembolism in acute lymphoblastic leukemia survivors treated on the NOPHO ALL2008 protocol

Epidemiology and Diagnosis of Post-Thrombotic Syndrome: Qualitative Synthesis with a Systematic Review

Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction

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