|Year : 2022 | Volume
| Issue : 4 | Page : 110-115
An observational study of the correlation between Clinical/Etiological/Anatomical/Pathophysiological, Venous Clinical Severity Score, and heaviness/ache/swelling/throbbing/itching classifications for chronic venous insufficiency
Xi Chen1, Yong-Feng Zhao2, Yong-Feng Han1, Li An1, Qian Yang1, Jun-Feng Zhao1, Yung-Wei Chi3, Li-Wen Liu1
1 Department of Ultrasound, The First Medical Center of Chinese PLA General Hospital, Beijing, China
2 Department of Ultrasound, The First Affiliated Hospital of the Air Force Medical University, Xi'an, China
3 Vascular Center, University of California, Davis, California, USA
|Date of Submission||16-Aug-2022|
|Date of Decision||10-Dec-2022|
|Date of Acceptance||11-Dec-2022|
|Date of Web Publication||15-May-2023|
Dr. Yung-Wei Chi
Vascular Center, University of California, Davis, 4860 Y Street, Sacramento, CA 95817
Source of Support: None, Conflict of Interest: None
OBJECTIVE: This study aimed to evaluate consecutive patients with chronic venous insufficiency (CVI) describing the relationship between Clinical/Etiological/Anatomical/Pathophysiological (CEAP) classification, leg heaviness/ache/swelling/throbbing/itching (HASTI) score, and Venous Clinical Severity Score (VCSS) and assessing the correlation between them.
MATERIALS AND METHODS: The CEAP classification, HASTI, and VCSS of consecutive patients were recorded, and their correlations were evaluated.
RESULTS: Four hundred eighty-four consecutive patients from March 2018 to March 2019 were studied. Significant correlations were detected between the HASTI and CEAP classification (F = 16.558, P < 0.001) and between VCSS and CEAP classification (F = 57.073, P < 0.001). The VCSS correlated more positively with CEAP (Spearman's correlation coefficient r = 0.740, P < 0.001) than HASTI (Spearman's correlation coefficient r = 0.536, P < 0.001). Using CEAP ≥2 as the cutoff, the areas under the receiver operating characteristics curve of the HASTI and VCSS were 0.694 and 0.774, respectively (P < 0.001 or both). The HASTI and VCSS cutoff values of 6.50 and 4.50, respectively, were identified as indicators of significant CVI with corresponding sensitivities of 63.8% and 78.7% and specificities of 65.6% and 47.0%, respectively.
CONCLUSION: Increasing HASTI and VCSS corresponded to increasing CEAP class in patients with CVI. The result may be applicable for early screening of patients with CVI.
Keywords: Clinical/etiological/anatomical/pathophysiological classification, heaviness/ache/swelling/throbbing/itching score, varicose vein of the lower extremity, VCSS
|How to cite this article:|
Chen X, Zhao YF, Han YF, An L, Yang Q, Zhao JF, Chi YW, Liu LW. An observational study of the correlation between Clinical/Etiological/Anatomical/Pathophysiological, Venous Clinical Severity Score, and heaviness/ache/swelling/throbbing/itching classifications for chronic venous insufficiency. Vasc Invest Ther 2022;5:110-5
|How to cite this URL:|
Chen X, Zhao YF, Han YF, An L, Yang Q, Zhao JF, Chi YW, Liu LW. An observational study of the correlation between Clinical/Etiological/Anatomical/Pathophysiological, Venous Clinical Severity Score, and heaviness/ache/swelling/throbbing/itching classifications for chronic venous insufficiency. Vasc Invest Ther [serial online] 2022 [cited 2023 Jun 4];5:110-5. Available from: https://www.vitonline.org/text.asp?2022/5/4/110/376920
| Introduction|| |
Chronic venous insufficiency (CVI) affects approximately one-third of the adult population (western countries) and results in significant psychological, physical, and financial burdens., In China, more than 100 million people suffer from the condition, with an incidence of 15.0%. Such a population is enormous, therefore, makes it is particularly important to standardize the screening of patients with CVI to avoid overwhelming an already exhausted health system. However, epidemiology on CVI in Shaanxi province remains scarce. At present, patients with CVI needed to rely on the results of ultrasonography for diagnosis. As such this created a huge burden on health-care expenditure and resources rendering patients either unable to receive timely treatment or were missed diagnosed. In this case, a complete clinical assessment is necessary so they could gain effective management.
This study aimed to evaluate the accuracy of the quantitative and qualitative assessments of patients with CVI by determining whether the heaviness/ache/swelling/throbbing/itching (HASTI) score and Venous Clinical Severity Score (VCS) correlated to the different stages of the Clinical/Etiological/Anatomical/Pathophysiological (CEAP) classification, and, if the correlation was established, to compare the degree of accuracy of the HASTI and VCSS to CEAP in the hope to identify quantitative criteria to triage CVI patients seeking care.
| Materials and Methods|| |
Between March 2018 and March 2019, 484 consecutive CVI patients referred for the duplex ultrasound of lower extremities at the First Affiliated Hospital of the Air Force Medical University were studied. The study was approved by the Institutional Review Board of the First Affiliated Hospital of the Air Force Medical University, the People's Republic of China. Informed consent was obtained from each patient. The research was performed per the ethical guidelines of the Declaration of Helsinki. Patients had to have at least one of the following for enrollment: Spider veins, varicose veins, skin discoloration, swelling, lipodermatosclerosis, healed ulceration, and active ulceration. Each patient underwent a lower limb venous ultrasound examination (HITACHI Ascendus, Tokyo, Japan; probe L75, 5–18MHz) and was required to complete both HASTI and VCSS questionnaires. A professional medical translation service was utilized to translate the questionnaires from English to Chinese. The demographic and clinical parameters of each patient, including age, gender, and previous medical history were evaluated. Patient characteristics are summarized in [Table 1].
The CEAP classification (CEAP), defined as the clinical (C), etiological (E), anatomical (A), and pathophysiological (P) aspects of CVI, was applied to objectively assess patients' clinical symptoms: C1, spider veins; C2, varicose veins; C3, edema; C4, pigmentation; C5, healed ulceration; and C6, active ulceration. The highest stage of CEAP was used to classify each patient.
A qualitative tool, the HASTI score was used for assessment. The HASTI score for varicose veins was derived from the answer to the question “How often have you had any of the following leg problems?” for each of the five HASTI symptoms (heavy legs, achy legs, swelling, throbbing, and itching) using a paper questionnaire and 1-week recall period. HASTI scores were recorded on a scale of 0–5 for each symptom (0 = no symptoms and 5 = most severe symptoms). Test validity was assessed using the correlation between the HASTI score and CEAP classification.
The Venous Clinical Severity Score (VCSS) was used as described in detail elsewhere. The score comprised 10 items consisted of clinical findings and the use of compression stockings: (1) Pain, (2) varicose veins, (3) edema, (4) pigmentation, (5) inflammation, (6) induration, (7) ulcer number, (8) ulcer size, (9) ulcer duration, and (10) compression use. Each item was scored on a scale of 0–3, yielding a 0–30 range for the complete VCSS. Test validity was assessed using the correlation between VCSS and CEAP classification.
Continuous data were expressed as the mean ± standard deviation. The one-way analysis of variance test was used to compare the differences in the mean values of the HASTI and VCSS with the CEAP class. Comparisons in the group of each method were performed using pairwise comparison. Correlations between the HASTI and VCSS and the stage of CEAP were assessed using Spearman's test. The results were illustrated as the median and 25th to 75th percentile values (box plots). P < 0.05 was considered statistically significant.
The diagnostic performances of the HASTI and VCSS were evaluated using receiver operating characteristics (ROC) curves; the ROC curves represented sensitivity versus 1-specificity for all possible cutoff values for the prediction of significant CVI. Here, an area under the curve (AUC) of 1.0 was characteristic of an ideal test, whereas 0.5 indicated a test of no diagnostic value. The optimal cutoff value was determined using a common optimization step maximizing the sum of the sensitivities in predicting single stages. SPSS version 13.0 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis.
| Results|| |
The relationship between the heaviness/ache/swelling/throbbing/itching score and Clinical/Etiological/Anatomical/Pathophysiological classification
The mean values of HASTI in patients with C1, C2, C3, C4, C5, and C6 were 3.47 ± 1.01, 6.65 ± 2.21, 8.41 ± 2.93, 10.42 ± 3.08, 11.65 ± 4.02, and 13.77 ± 4.75, respectively. Significant differences were observed between C1/C2, C2/C3, C3/C4, C4/C5, C5/C6, and C1/C6 (P < 0.001) [Table 2]. In the comparison between CEAP classification and HASTI, there was a positive correlation showing increasing HASTI corresponded to increase in CEAP class. Spearman's correlation coefficient between HASTI and CEAP was moderate (r = 0.536, P < 0.001) [Figure 1]a. In addition, Spearman's correlation coefficient between HASTI and CEAP of females was higher than males (male: r = 0.499, female: r = 0.556, P < 0.001 or both).
|Figure 1: (a) Correlation between the HASTI to CEAP. The top and bottom of the boxes represent the first and third quartiles, respectively. The lengths of the boxes denote the interquartile ranges within which 50% of the values are located. The thick line in each box represents the median. Error bars mark the minimum and maximum values (range). Circles denote outliners. Significant differences were observed between the CEAP stage and HASTI score (P < 0.001). (b) Correlation between the VCSS to CEAP. The top and bottom of the boxes represent the first and third quartiles, respectively. The lengths of the boxes denote the interquartile ranges within which 50% of the values are located. The thick line in each box represents the median. Error bars mark the minimum and maximum values (range). Circles denote outliners. Significant differences were observed between the CEAP stage and VCS score (P < 0.001). HASTI: Heaviness/ache/swelling/throbbing/itching, CEAP: Clinical/etiological/anatomical/pathophysiological|
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|Table 2: Test responsiveness: Heaviness/ache/swelling/throbbing/itching and venous clinical severity score|
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The relationship between the VCSS and Clinical/Etiological/Anatomical/Pathophysiological classification
The mean values of VCSS from C1 to C6 were 3.11 ± 0.53, 4.97 ± 1.83, 6.95 ± 2.14, 9.17 ± 2.78, 14.00 ± 3.21, and 16.64 ± 4.75, respectively. Significant differences were observed between C1/C2, C2/C3, C3/C4, C4/C5, C5/C6, and C1/C6 (P < 0.001) [Table 2]. Spearman's correlation coefficient between the VCSS and stages of CEAP classification was highly positive (r = 0.740, P < 0.001) [Figure 1]b. In addition, Spearman's correlation coefficient between VCSS and CEAP of males was slightly higher than females (male: r = 0.744, female: r = 0.725, P < 0.001 or both).
Comparing between heaviness/ache/swelling/throbbing/itching and VCSS
Using CEAP stage ≥ C2 as the clinical criteria, the AUCs of HASTI and VCSS were 0.694 and 0.774, respectively. Comparisons between the AUCs of the two methods revealed that there was a statistical difference between them (P < 0.001). Although both questionnaires correlated to CEAP class, the AUC results determined that VCSS was superior to HASTI [Figure 2] (P < 0.001). Concerning the distribution of HASTI and VCSS vis-à-vis the classes of CEAP, the cutoff values were determined to be 6.50 and 4.50, respectively, for CEAP ≥ C2. Using these cutoff values, the sensitivities for significant CVI were 63.8% and 78.7%, and the specificities were 65.6% and 47.0%, respectively [Table 3].
|Figure 2: The ROC curve of HASTI and VCSS for CEAP class >− C2. As the clinical criteria, the AUCs of HASTI and VCSS were 0.694 and 0.774, respectively, the cutoff values were determined to be 6.50 and 4.50, respectively (P < 0.001). ROC: Receiver operating characteristics, HASTI: Heaviness/ache/swelling/throbbing/itching, CEAP: Clinical/etiological/anatomical/pathophysiological, AUC: Area under curve|
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|Table 3: Cutoff values of heaviness/ache/swelling/throbbing/itching and Venous Clinical Severity Score for assessing significant chronic venous insufficiency (clinical/etiological/anatomical/pathophysiological ≥C2)|
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| Discussion|| |
The CEAP classification was introduced in 1996, combining the clinical (C), etiological (E), anatomical (A), and pathophysiological (P) aspects of CVI, and it has become widely accepted as the standard classification system for venous disorders., Some clinical components of CEAP such as C5 (healed ulceration) and C4 (lipodermatosclerosis and pigmentation) are unchangeable or resolve very slowly over time even after therapeutic interventions. Hence, the clinical CEAP classification is far more recognized as a discriminative or descriptive tool than a quantitative instrument. To describe gradual changes after treatments, other instruments are needed. As a result, the VCSS was introduced in 2000 as an adjunct to CEAP and widely accepted as a benchmark assessment tool along with CEAP in clinical practice and scientific studies.,,,
VCSS has been developed for scoring the entire spectrum of venous diseases, from asymptomatic venous disease to severe postthrombotic syndrome. The 10-item score consists of nine symptom attributes and the use of compression therapy. Three out of the ten attributes refer to the number of venous ulcers, ulcer duration, and ulcer size., Thus, VCSS emphasizes the more advanced stages of CVI,,, which are either not included,,, or represent a minority in current clinical trials on varicose vein treatment. Moreover, as an objective tool, i.e., health-care providers typically fill it out, more recently various authorities have recommended it be use qualitatively as a patient-reported outcome assessment, i.e., the patients fill it out. The objectiveness versus subjectiveness of this tool remains to be further studied.
Lately, patient-reported outcome questionnaire has become an essential tool both in clinical practice and research. Many of such questionnaires existed but the HASTI score is one of the easiest to use. It comprises five referenced symptoms including leg heaviness, achiness, swelling, throbbing pain, and itching; each item is ranked 0–5, with 5 being the most severe.
The current situation of patients with CVI in Xijing Hospital is not promising. The number of patients with CVI was large; about 4893 patients were diagnosed during the 1-year study period yet only 484 consecutive patients (or 9.9%) were referred for an ultrasound examination. This suggested a paucity in CVI recognition in clinical practice. In addition, patients lacked awareness of varicose veins thinking they were normal part of the aging process even in those with symptoms. Moreover, in China guidance to assist doctors in screening clinical symptoms of varicose veins still lagged behind Western countries. Unless objective tools are utilized, patients may never find optimal care of such disorders.
In our study patients with C2 outnumbered those at other stages (42.8%), followed by C4 (32.4%). Both VCSS and HASTI correlated with CEAP demonstrating an increase in score paralleled an increase in CEAP class albeit VCSS signified a superiority over HASTI. Despite this, both assessments should be used as each targeted for different purposes; VCSS, an objective tool while HASTI is more subjective in nature as previously described. The results of this study were similar to those reported by Passman et al.
The accuracy of quantitative assessments in this study included additional analyses on HASTI and VCSS as determinants for significant CVI. Using CEAP ≥ C2 as the criterion for evaluation, the ROC revealed that a VCSS of 4.50 and HASTI of 6.50 to be optimal cutoffs for clinically significant CVI. Particularly, many have advocated the use of at least a score of 5 on VCSS before intervention for CVI. This corresponded to our finding that VCSS of 4.50 to be clinically significant. While VCSS indicated a higher sensitive of 79% to that of HASTI, 64%, specificity was higher for HASTI than VCSS. This again reiterated the recommendation that both objective assessment such as VCSS and patient-reported outcome tool, HASTI should be used inconcert. Utilizing such tools to screen patients may improve access to much needed care while avoiding overwhelming an exhausted health-care system.
This study must be interpreted with caution in light of several limitations. First, ultrasound findings were not reported as it was not the focus of this study. Second, the total numbers in C1 and C6 were low which may cause the final conclusion subjected to statistical bias.
| Conclusion|| |
In summary, our results demonstrated that HASTI and VCSS could provide improved screening of patients with significant CVI in Northwest China. This may translate to a significant boost in the management of such patients. Further advances in patient education and disease recognition among health-care providers will better define the effectiveness of HASTI and VCSS in assessing CVI patients in China.
We want to thank Dr. Jiang-Hao Chen (Department of Vascular Surgery, the First Affiliated Hospital of the Air Force Medical University, Xi'an, China) for his contributions to our study. This study was supported by a grant from the Shaanxi Provincial Natural Science Foundation of China (# XJZT19ML44).
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]