Improvement in quality of life with treatment of chronic venous disease: A longitudinal observational study in Kandy,Sri Lanka

Abstract

Objective

This study assessed the improvement in Quality of Life (QoL) of Chronic Venous Disease (CVD) patients in Sri Lanka following treatment.

Methods

This was a prospective observational study of 58 newly or previously diagnosed CVD patients. QoL was assessed by the 14-item ChronIc Venous dIsease quality of life Questionnaire (CIVIQ-14) at 4 and 8 weeks after treatment.

Results

At 8 weeks, the improvement in Global score from baseline was greatest in the surgical group with adjusted least squares mean of 23.5 (p < 0.001) followed by the non-surgical group at 13.3 (p < 0.001). There was no significant improvement in the no-treatment group at 0.333 (p = 0.950). Similar results were obtained for Pain and Physical domain scores at 8 weeks. Likewise, at 4 weeks, Global score and Pain and Physical domain scores showed significant improvement in the surgical and non-surgical groups (all p < 0.001) only.

Conclusion

Both surgical and non-surgical treatments improved QoL of CVD patients.

Keywords

Chronic venous disease treatment quality of life Chronic Venous Insufficiency Quality of life Questionnaire

Introduction

Chronic Venous Disease (CVD) is a common chronic disease of the venous system of the legs which affects patients’ health and well-being.^1,2 Venous hypertension, vein-wall weakness and valvular incompetence result in edema, varicose veins, skin changes and where severe, venous ulcers.^1,3,4 The Clinical-Etiology-Anatomy-Pathology (CEAP) classification describes the spectrum of CVD from C0 to C6.²

The Vein Consult Program (VCP), carried out in 23 countries from 2009 to 2013, showed that CVD is common with a prevalence of 63.7% worldwide and 51.9% in Asia.⁵ The prevalence is expected to increase given the growing prevalence of obesity, a risk factor of CVD.^5,6 This is especially so for low-to-middle-income countries (LMICs) like Sri Lanka where approximately 25% of the population suffer from metabolic syndrome.⁷ CVD treatment helps to reduce symptoms and prevent complications of CVD which adversely affect Quality of Life (QoL).⁸ Treatment can be supportive, medical or surgical, with minimally-invasive techniques (e.g. sclerotherapy, endovascular laser ablation) becoming increasingly popular.^8,9

The CVD-specific ChronIc Venous dIsease quality of life Questionnaire (CIVIQ-14) considers three dimensions of QoL (pain, physical, psychological), and is a reliable tool in many international CVD studies.^10–12 CVD patients have a significantly reduced QoL due to symptoms such as pain and swelling, which limit their ability to ambulate and work. QoL was most affected in patients with higher CEAP classification and increased symptom severity.^10,12,13

A high disease burden of CVD in Sri Lanka is expected, given the growing prevalence of metabolic syndrome. However, there is a lack of QoL studies of CVD patients in Sri Lanka. Thus, the primary aim of this study was to assess how treatment would improve QoL of CVD patients in Sri Lanka. We hypothesized that QoL improves with treatment. The secondary aim was to compare the improvement in QoL across different treatment groups. The final aim was to assess the perceptions and treatment-seeking behaviors of CVD patients.

Materials and methods

We used the STROBE cohort checklist for this report.¹⁴

Study setting and design

A prospective observational study was conducted at Teaching Hospital Peradeniya, Kandy, Sri Lanka. Patients were recruited from October to December 2019 and followed up until February 2020. We aimed to enrol 50 patients, i.e. 80% power at alpha 0.05, to detect a clinically relevant effect size of 0.4 in QoL in the overall sample from before to after treatment. The study was approved by the Institutional Review Boards of the University of Peradeniya (2019/EC/64) and the National University of Singapore (N-19-088E). All patients provided written informed consent.

Sampling and selection strategy

Eligible patients were at least 18 years of age, either previously diagnosed with CVD and untreated in the past 6 months or newly diagnosed. Exclusion criteria were conditions associated with limb edema or affecting limb sensation and circulation; deep vein thrombosis; traumatic injury; or surgical or percutaneous procedures to the lower extremities in the last 6 months.

Initial evaluation

Data such as sociodemographics, risk factors for CVD, CVD symptoms and CVD clinical stage were collected before treatment. The intensity of the ten symptoms of CVD (dull aching, pain, leg heaviness, swelling, tightness, skin itching, muscle cramps, burning sensation, tingling sensation, tiredness) was assessed using the Verbal Numeric Scale (VNS, with 0 and 10 being the least and most intense for each symptom). A surgeon examined the patient’s leg to determine CEAP classification² (C0, no signs of CVD; C1, venous telangiectasias; C2, varicose veins; C3, edema; C4, venous stasis and skin changes; C5, healed venous ulcers; and C6, open venous ulcers).

Treatment

Treatment options were offered by the surgeon based on each patient’s condition. Surgical treatment included multiple stab avulsions, vein ligation, vein stripping, and venous ulcer wound debridement. Non-surgical treatment included sclerotherapy and endovenous laser ablation (EVLA). Supportive treatment included compression stockings, four-layer bandaging, and medications for symptomatic relief.

Quality of life questionnaire

The CIVIQ-14 (Supplementary I) was translated into Sinhala by a Sinhala-speaking research assistant and verified by a sworn translator. An additional qualitative survey regarding perceptions of CVD and treatment-seeking behaviors was administered. Both surveys were administered in Sinhala by a research assistant and recorded in English.

Follow-up

Follow ups were at two time points: 4 weeks and 8 weeks after treatment, via a clinic appointment or a phone-call if an appointment was not required or defaulted. Patients were reassessed for symptom severity and QoL and compensated 300 Sri Lankan Rupees.

Variables and covariates

The primary outcome was change in QoL as measured by the CIVIQ-14 Global score from before treatment (baseline) to 4 and 8 weeks after treatment. The CIVIQ-14 consists of three domains: Pain (3 items), Physical (5 items), and Psychological (6 items), with each item scored on a 5-point Likert scale. A Global score was obtained by summing scores for the 14 items. The Global and domain scores were converted into an index¹⁵ ranging from 0 (terrible quality of life) to 100 (excellent quality of life). A clinically meaningful improvement in QoL was defined as an increase in Global score of at least 5 points. Sociodemographics, risk factors for CVD, symptom severity and clinical stage were considered as covariates.

Statistical analysis

Continuous demographic data (e.g. age, body mass index [BMI]), symptom severity and QoL scores were summarized using mean and standard deviation. One-way analysis of variance was used to compare means of continuous, normally-distributed patient baseline demographic and clinical variables among the three treatment groups (surgical, non-surgical, no-treatment). The Kruskal-Wallis test was used to compare medians of non-normally distributed variables. Demographic categorical and count data (e.g. sex, CEAP classification, total number of symptoms) were reported using frequencies and percentages. Fisher’s exact test was used to compare categorical variables. Missing BMI and income values were not imputed.

For the primary and secondary aims, a general linear mixed model analysis was used to compare mean CIVIQ-14 QoL scores and change from baseline in scores among the three treatment groups (surgical, non-surgical, no-treatment) at 4- and 8-weeks follow-up times. Post-hoc significance levels were not adjusted for multiple comparisons, as the omnibus F-test controls the family-wise type I error to the nominal level. For all tests, a p-value of <0.05 was considered statistically significant. The primary analysis was supplemented with a qualitative review of the perceptions of CVD and treatment-seeking behaviors. Statistical analysis was performed using SAS Version 9.4.

Results

Patient demographics and baseline clinical characteristics

A flowchart of patients recruited is at Figure 1. A total of 58 patients were recruited and followed up at 4 and 8 weeks. 8 patients lost to follow-up were excluded in the analysis. Patient demographics and baseline clinical characteristics by treatment group are at Table 1. The mean age was 54.3 years with 37 females. 15 patients were classified as mild CVD (C2) while 43 patients were classified as severe CVD (C3–C6). No C0 and C1 patients were recruited. There were no significant differences in risk factors amongst treatment groups except for family history of CVD (p = 0.029), present in 22 patients.

Figure 1.

Flowchart showing patients included in the observational study.

Table 1.

Patient demographics and baseline clinical characteristics, overall and by treatment group.

Characteristics	Total	Surgical	Non-surgical	No treatment	P-value
Characteristics	n = 58	n = 23	n = 27	n = 8	P-value
Age (years), mean (SD)	54.3 (12.8)	54.1 (12.3)	55.9 (13.1)	49.5 (13.8)	0.475
Sex, n (%)					0.065
Female	37 (63.8)	13 (56.5)	16 (59.3)	8 (100)
Male	21 (36.2)	10 (43.5)	11 (40.7)	0 (0.00)
BMI (kg/m²), mean (SD) (n = 33)	26.1 (4.56)	26.4 (5.76)	25.8 (3.54)	26.3 (5.04)	0.946
Income (Mo. Rs/1000), (n = 51)^a	30 (15, 51)	30 (20, 35)	40 (15, 60)	40 (15, 60)	0.405
Duration of CVD (years), (n = 57)^a	11 (4, 25)	10 (2, 20)	13.5 (4, 25)	11 (4, 22.5)	0.645
Yr since last CVD surgery, (n = 21)^a	8 (4, 15)	4.5 (3, 17.5)	8 (2, 15)	28.5 (10, 47)	0.378
CEAP classification, n (%)^b					0.658
Mild CVD (C2)	15 (25.9)	5 (21.7)	7 (25.9)	3 (37.5)
Severe CVD (C3 – C6)	43 (74.1)	18 (78.3)	20 (74.1)	5 (62.5)
Comorbidities, n (%)
Hypertension	20 (34.5)	8 (34.8)	11 (40.7)	1 (12.5)	0.387
Hyperlipidemia	21 (36.2)	8 (34.8)	11 (40.7)	2 (25)	0.809
Diabetes mellitus	12 (20.7)	5 (21.7)	6 (22.2)	1 (12.5)	1.000
Potential risk factors
Family history of CVD, n (%)	22 (37.9)	4 (17.4)	27 (46.6)	4 (50.0)	0.029
Level of exercise (hrs/week)^a	0 (0, 0)	0 (0, 0)	0 (0, 0)	0 (0, 0)	0.091
Among women (n = 37)	37	13	16	8
Number of births^a	3 (2, 3)	3 (1, 4)	3 (1.5, 3)	2.5 (2, 3)	0.741

BMI, body mass index; SD, standard deviation; Mo. Rs; monthly Sri Lankan rupees; Yr, years; CVD, chronic venous disease; CEAP, Clinical-Etiologic-Anatomic-Pathophysiologic.Bold values were results that met statistical significance of p<0.05.

^aReported as median (interquartile range) and compared using the Kruskal-Wallis test.

^bNo C0 and C1 recruited.

Treatment

27 patients received non-surgical treatment (46.6%), 23 patients received surgery (39.7%) while 8 patients declined or were not prescribed treatment (13.8%). The non-surgical group comprised patients who received either sclerotherapy, EVLA or supportive treatment as these three treatment groups had small sample sizes.

Chronic venous disease symptoms

The most frequent CVD symptoms reported at baseline were pain (n = 49) and dull aching (n = 42) (Table 2). Patients experienced a mean of 5.93 (SD 2.34) symptoms. There were no significant differences in total number of symptoms at baseline between the surgical, non-surgical and no-treatment groups with means of 5.70, 6.04 and 6.25 respectively (p = 0.809) (Table 3). Baseline VNS scores were significantly associated with change from baseline scores (p < 0.001) and hence adjusted for. At 8 weeks, reduction in number of symptoms from baseline was statistically significant for the surgical (LSM=−3.95) and non-surgical (LSM=−3.57) groups (both p < 0.001), but not significant for the no-treatment group (LSM=−0.081). Reduction in number of symptoms from baseline between the surgical and non-surgical groups did not differ significantly, but both groups differed significantly from the no-treatment group (p < 0.05). The same pattern held for all other CVD symptoms where the F-test indicated significant differences among groups.

Table 2.

Summary of chronic venous disease symptoms at baseline (Week 0).

Most common CVD symptoms	n	%	VNS, mean (SD)
Dull aching	42	72.4	4.53 (3.57)
Pain	49	84.5	5.40 (3.38)
Leg heaviness	26	44.8	2.26 (2.93)
Swelling	48	82.8	4.33 (2.91)
Tightness	29	50.0	2.22 (2.72)
Skin itching	27	46.6	2.57 (3.41)
Muscle cramps	35	60.3	3.34 (3.26)
Burning sensation	24	41.4	2.24 (3.28)
Tingling sensation	30	51.7	2.90 (3.34)
Tiredness	36	62.1	3.34 (3.02)
Number of symptoms^a	5.93 (2.34)

Time when CVD symptoms appear at highest intensity	n	%

In the morning	13	22.4
At the end of the day	11	19.0
During the night	25	43.1
After prolonged sitting	13	22.4
After prolonged standing	46	79.3
While walking	38	65.5

CVD, chronic venous disease; VNS, verbal numeric scale; SD, standard deviation.

^aTotal number of CVD symptoms present reported as mean (SD).

Table 3.

CVD VNS symptom severity scores: Treatment group comparisons among LSM at Weeks 0 and 8.

CVD symptoms	Follow-upWeek	VNS Symptom Severity:Week 0, Mean (SD) Week 8, LSMΔVNS Symptom Severity, LSM Differences
CVD symptoms	Follow-upWeek	Surgical (S)	Non-surgical (NS)	No treatment (NT)	P-value
Dull aching	Week 0	4.61 (3.87)	4.11 (3.52)	5.75 (2.87)	0.526
	Week 8^a	0.639	1.41	5.15	<0.001
	ΔWk8-0^a	–3.90***	–3.12***	0.619	<0.001 ^c

Pain	Week 0	5.13 (3.56)	5.07 (3.53)	7.25 (1.49)	0.250
	Week 8^a	1.15	1.71	4.93	0.008
	ΔWk8-0^a	–4.25***	–3.69***	–0.462	0.008 ^c

Leg heaviness	Week 0	2.09 (2.63)	2.22 (3.15)	2.88 (3.27)	0.809
	Week 8^a	0.409	1.26	2.81	0.035
	ΔWk8-0^a	–1.85***	–0.996**	0.554	0.035 ^c

Swelling	Week 0	3.91 (2.57)	4.00 (3.13)	6.63 (2.20)	0.052
	Week 8^a	0.628	1.60	2.54	0.071
	ΔWk8-0^a	–3.70***	–2.73***	–1.78*	0.071

Tightness	Week 0	1.96 (2.50)	2.52 (2.93)	2.00 (2.88)	0.750
	Week 8^a	0.699	0.763	2.16	0.129
	ΔWk8-0^a	–1.53***	–1.46***	–0.060	0.129

Skin itching	Week 0	2.57 (3.40)	3.22 (3.68)	0.38 (1.06)	0.116
	Week 8^a	0.957	1.01	1.33	0.930
	ΔWk8-0^a	–1.61**	–1.56**	–1.24	0.930

Muscle cramps	Week 0	2.87 (3.38)	3.52 (3.31)	4.13 (2.90)	0.607
	Week 8^a	0.522	1.06	3.18	0.014
	ΔWk8-0^a	–2.82***	–2.29***	–0.166	0.014 ^c

Burning sensation	Week 0	2.39 (3.61)	2.11 (2.98)	2.25 (3.65)	0.957
	Week 8^a	0.541	0.799	2.25	0.140
	ΔWk8-0^a	–1.70***	–1.44***	0.007	0.140

Tingling sensation	Week 0	2.39 (3.26)	3.26 (3.29)	3.13 (3.98)	0.651
	Week 8^a	0.535	0.737	3.85	0.004
	ΔWk8-0^a	–2.36***	–2.16***	0.953	0.004 ^c

Tiredness	Week 0	2.30 (2.77)	3.89 (3.04)	4.50 (3.07)	0.090
	Week 8^a	0.357	1.13	3.16	0.011
	ΔWk8-0^a	–2.99***	–2.22***	–0.181	0.011 ^c

Number of symptoms^b	Week 0	5.70 (2.49)	6.04 (2.44)	6.25 (1.58)	0.809
	Week 8^a	1.98	2.36	5.85	0.012
	ΔWk8-0^a	–3.95***	–3.57***	–0.081	0.012 ^c

CVD, chronic venous disease; VNS, verbal numeric scale; SD, standard deviation; LSM, least squares mean; Week 0, baseline symptom severity at Week 0; Week 8, symptom severity at Week 8; ΔWk8-0, Week 8 – Week 0 difference.Bold values were results that met statistical significance of p<0.05.

^aLeast squares means adjusted for baseline values.

^bTotal number of CVD symptoms present reported as mean (SD).

^cSurgical and Non-Surgical not significantly different; Surgical and Non-Surgical both significantly different from No Treatment (p < 0.05).

*Significant change from baseline: p < 0.05, **p < 0.01, ***p < 0.001.

Quality of life scores

QoL scores by treatment groups at baseline, 4 weeks and 8 weeks are at Table 4. Baseline QoL scores were significantly associated with change from baseline scores (p < 0.001) and hence adjusted for. QoL scores were not adjusted for age, sex, BMI or family history of CVD as they had no significant effect on change from baseline scores. For Global and domain scores, a higher score indicated a better QoL. For change from baseline scores, a positive difference in the scores indicated an improvement in QoL. At baseline, there were no significant differences in Global and domain scores amongst the groups.

Table 4.

CIVIQ-14 QoL scores: Treatment group comparisons among LSM at Weeks 0, 4 and 8; and among LSM at Week 4 and 8 compared to Week 0.

CIVIQ-14 Domains	Follow-upWeek	CIVIQ-14 Scores:Week 0, Mean (SD)Week 4 & Week 8, LSMΔCIVIQ-14 Scores, LSM Differences				ΔWk4-0, ΔWk8-0 Pairwise Comparisons: LSM Difference (95% CI) P-value
CIVIQ-14 Domains	Follow-upWeek	Surgical(S)	Non-Surgical (NS)	No Treatment (NT)	P-value	S vs NS	S vs NT	NS vs NT
Global	Week 0	71.0 (16.7)	75.9 (17.5)	64.1 (19.1)	0.232
	Week 4^a	91.3	87.0	74.5	0.032	4.35(−4.13, 12.8)0.312	16.8(4.54, 29.1)0.008	12.5(0.325, 24.6)0.044
	ΔWk4-0^a	19.0***	14.7***	2.21	0.028^b	4.35(−4.13, 12.8)0.312	16.8(4.54, 29.1)0.008	12.5(0.325, 24.6)0.044

	Week 8^a	95.9	85.6	72.7	0.001	10.3(1.80, 18.8)0.018	23.2(10.9, 35.5)<0.001	12.9(0.793, 25.1)0.037
	ΔWk8-0^a	23.5***	13.3***	0.333	<0.001^b	10.3(1.80, 18.8)0.018	23.2(10.9, 35.5)<0.001	12.9(0.793, 25.1)0.037

Pain	Week 0	57.6 (26.8)	68.5 (27.2)	49.0 (16.9)	0.123
	Week 4^a	86.7	85.9	70.4	0.170	0.816(−11.4, 13.0)0.895	16.2(−1.27, 33.8)0.069	15.4(−1.96, 32.8)0.082
	ΔWk4-0^a	25.2***	24.3***	8.93	0.162^b	0.816(−11.4, 13.0)0.895	16.2(−1.27, 33.8)0.069	15.4(−1.96, 32.8)0.082

	Week 8^a	95.0	82.8	64.2	0.003	12.2(0.044, 24.4)0.049	30.8(13.3, 48.3)<0.001	18.6(1.20, 36.0)0.036
	ΔWk8-0^a	33.5***	21.3***	2.68	<0.001^b	12.2(0.044, 24.4)0.049	30.8(13.3, 48.3)<0.001	18.6(1.20, 36.0)0.036

Physical	Week 0	67.0 (24.3)	68.5 (26.3)	53.1 (24.6)	0.315
	Week 4^a	84.2	83.7	63.6	0.044	0.537(−11.0, 12.1)0.927	20.6(3.81, 37.4)0.017	20.1(3.56, 36.6)0.018
	ΔWk4-0^a	18.4***	17.9***	−2.16	0.040^b	0.537(−11.0, 12.1)0.927	20.6(3.81, 37.4)0.017	20.1(3.56, 36.6)0.018

	Week 8^a	91.6	82.4	62.4	0.004	9.22(−2.29, 20.7)0.115	29.2(12.4, 46.0)<0.001	20.0(3.51, 36.5)0.018
	ΔWk8-0^a	25.8***	16.6***	−3.41	0.003^b	9.22(−2.29, 20.7)0.115	29.2(12.4, 46.0)<0.001	20.0(3.51, 36.5)0.018

Psychological	Week 0	81.0 (16.9)	85.6 (12.8)	80.7 (19.7)	0.515
	Week 4^a	93.3	90.9	83.2	0.204	2.26(−10.4, 14.9)0.724	27.2(8.93, 45.4)0.004	-24.9(6.97, 42.8)0.007
	ΔWk4-0^a	2.80	0.538	−24.3**	0.011^b	2.26(−10.4, 14.9)0.724	27.2(8.93, 45.4)0.004	-24.9(6.97, 42.8)0.007

	Week 8^a	97.3	90.1	83.2	0.031	11.0(−1.71, 23.6)	35.8(17.6, 54.0)	24.8(6.92, 42.8)
	ΔWk8-0a	10.2*	−0.759	−25.6**	<0.001^b	0.089	<0.001	0.007

Interpretation of CIVIQ-14 scores: The higher the score, the better the quality of life. Interpretation of ΔWk4-0 and ΔWk8-0: A positive difference in the scores indicates an improvement in quality of life. CIVIQ-14, ChronIc Venous dIsease quality of life Questionnaire; SD, standard deviation; LSM, least squares mean; 95% CI, 95% confidence interval; Week 0, baseline QoL score; Week 4, QoL score at Week 4; Week 8, QoL score at Week 8; ΔWk4-0, Week 4 – Week 0 difference; ΔWk8-0, Week 8 – Week 0 difference.Bold values were results that met statistical significance of p<0.05.

*Significant change from baseline: p < 0.05, **p < 0.01, ***p < 0.001.

^aLeast squares means adjusted for baseline values.

^bF-test comparing change from baseline among treatment groups (2 degrees of freedom) as a pre-test to pairwise comparisons.

At 8 weeks, the improvement in Global score from baseline was greatest in the surgical group with adjusted LSM of 23.5 (p < 0.001); the non-surgical group improved by 13.3 (p < 0.001); and there was no improvement in the no-treatment group at 0.333 (p = 0.950). Similar results were obtained for the Pain and Physical domain scores at 8 weeks, i.e. significant improvement in the surgical and non-surgical groups (all p < 0.001) but no significant improvement in the no-treatment group (all p ≥ 0.246). At 8 weeks, improvement from baseline was significantly greater in the surgical group compared to the non-surgical group for the Global score (p = 0.018) and Pain domain score (p = 0.049), but not for the Physical or Psychological domain scores (p = 0.115 and p = 0.089 respectively).

Likewise, at 4 weeks, Global scores and Pain and Physical domain scores showed significant improvement in the surgical and non-surgical groups (all p < 0.001), but not in the no-treatment group. However, there were no significant differences in improvement from baseline between the surgical and non-surgical groups for Global and all domain scores. None of the groups exhibited significant improvement in the Psychological domain at week 4, and only the surgical group showed a significant improvement in the Psychological domain at week 8 (p < 0.05). At 4 and 8 weeks, there was a significant negative change (deterioration) from baseline (both p < 0.01) for the Psychological domain in the no-treatment group.

Qualitative analysis

The top three reasons given by patients for cause of CVD was previous pregnancy (n = 12), prolonged standing (n = 11) and genetics (n = 10) (Table 5). Prolonged standing, being overweight and high parity (87.9%, 86.2% and 75.9% respectively) were the most common risk factors of CVD. The main reasons for seeking treatment at this time were an increase in symptoms (n = 31) or the presence of a wound (n = 18).

Table 5.

Summary of perceptions of CVD and treatment-seeking behaviours.

Questions	Responses	Frequencies	Percentages
Reason to get CVD	Previous pregnancy	12	20.7
	Prolonged standing	11	19.0
	Genetics	10	17.2
	No idea	9	15.5
	Being overweight	7	12.1
	Heavy lifting	5	8.6
	Others	4	6.9

Risk factors of CVD ^a	Prolonged standing	51	87.9
	Overweight	50	87.8
	High parity	44	75.9
	Genetics	37	63.8
	Previous DVT	32	55.2
	Sedentary lifestyle	24	41.4
	Being female	21	36.2
	Prolonged sitting	12	20.7

Previous treatment sought	Surgical treatment	22	37.9
	No treatment	15	25.9
	Non-surgical treatment	11	19.0
	Traditional treatment	10	17.2

Main reason for current visit	Increased symptoms	31	53.5
	Presence of wound	18	31.0
	Doctor referral	9	15.5

Reason for treatment choice	Prescribed by doctor	50	86.2
	Others	8	13.8

CVD, chronic venous disease; DVT, deep vein thrombosis.

^aOnly ‘Yes’ responses presented for Yes/No questions.

Discussion

Surgical and non-surgical treatments improved QoL significantly (as measured by the CIVIQ-14 Global score) from before treatment (baseline) to 4 and 8 weeks after treatment, confirming our hypothesis. There was no significant improvement in the no-treatment group at 4 and 8 weeks. Qualitative analysis showed that most patients perceived previous pregnancy, prolonged standing and genetics as reasons for CVD. Increased symptoms prompted patients to seek treatment.

Quality of life

CVD is a progressive disease with increasing symptom severity if left untreated. CVD progressed in 57.8% of 334 patients during a 13-year follow-up period in the Edinburgh Vein study.¹⁶ Without treatment, persistent inflammation in the venous system leads to a higher CEAP class and worsening symptoms such as pain, thus reducing QoL.¹⁷

The burden of chronic diseases is substantial for LMICs like Sri Lanka, as chronic diseases account for 80% of all deaths in LMICs.⁷ The progressive and chronic nature of CVD confers increased morbidity for CVD patients. This is worsened by the limited resources of Sri Lanka’s healthcare system and the low expenditure on healthcare, which has averaged less than 2 percent of its gross domestic product throughout the last 50 years—less than the World Health Organization’s recommendation of 5 percent.¹⁸ The symptoms and complications of CVD have a direct impact on patient QoL, affecting their ability to perform activities of daily living.^6,12 It is therefore important to assess the QoL of CVD patients pre- and post-treatment to assess how timely treatment prevents disease progression and decreases the disease burden of CVD in Sri Lanka.

Various treatments for CVD relieve symptoms and slow CVD progression, hence improving QoL.¹⁷ We found that surgical and non-surgical treatments reduced the total number of symptoms, and pain VNS scores had the most significant reduction at 8 weeks. The RELIEF study, a multicenter international study involving 18 countries including Sri Lanka, showed that 63.3% of 3956 patients experienced an improvement in symptoms of swelling, heaviness, cramps and pain 6 months after treatment with micronized purified flavonoid fraction (MPFF).¹⁹ Global scores on the CIVIQ-20 also improved from 64.1 at baseline to 73.1 at 8 weeks post-treatment. This improvement in QoL was greater at 4 and 6 months. We found similar improvements. At 8 weeks after treatment, the Global scores of the surgical and non-surgical groups improved from 71.0 to 95.9 and 75.9 to 85.6 respectively. A randomised, placebo-controlled trial of compression stockings also showed a reduction in limb swelling and improved Global scores after 4 weeks.²⁰ These studies showed that CVD treatment significantly improved QoL. Similarly, our results showed that improvements in symptoms paralleled improvements in CIVIQ scores. A clinically meaningful improvement of five points on the Global score was seen in the surgical and non-surgical groups, but not in the no-treatment group.

Besides CIVIQ, other studies utilizing the Aberdeen Varicose Vein Questionnaire (AVVQ) showed that surgical treatment improved QoL in CVD patients 6 weeks post-treatment.^21,22 Non-surgical treatment (i.e. sclerotherapy, wound dressing, compression stockings) improved QoL and pain at 4 weeks post-treatment.²³ Randomized controlled trials (RCT) comparing sclerotherapy, EVLA and surgery demonstrated significant improvements in QoL with no substantial between-group differences.^24–26 Likewise, we observed no statistically significant differences between the surgical and non-surgical groups in the improvement of Global and all domain scores from baseline to 4 weeks.

Our study showed that QoL improvement in Global and Pain domain scores from baseline were significantly greater with surgical treatment compared to non-surgical treatment at 8 weeks, but not at 4 weeks. This may be due to postoperative pain, swelling and hematoma experienced by patients in the first 4 weeks post-surgery. In addition, the non-surgical group may experience less postoperative pain due to the less invasive treatment nature. A meta-analysis showed that compared to surgery, EVLA had significantly lower postoperative pain scores.²⁷

Although in our study the surgical group had the greatest improvement in symptoms and QoL scores at 8 weeks, RCTs comparing different treatment modalities showed that QoL scores for conventional surgery were not significantly different 3 to 5 years after treatment.^25,28 Hence, both surgical and non-surgical treatments could improve QoL similarly with no greater benefit over the other.

Perceptions of chronic venous disease

Most patients believed that previous pregnancy, prolonged standing and genetics caused their CVD. Results from the VCP, identified positive family history, number of pregnancies, prolonged standing or sitting and lack of regular exercise as possible risk factors of CVD.⁵ While the prevalence of risk factors varied by geographical regions, a positive family history was the most significant risk factor, suggesting the heritability of CVD.²⁹ In our study, patients sought treatment due to increased CVD symptoms. A systematic review found that the most common reason for seeking treatment was symptom relief for bothersome CVD symptoms.³⁰ Thus, understanding patient perceptions of CVD can help physicians better advise CVD patients on effective symptom control and appropriate treatment options.

Strengths and limitations

There was a trend in improvement of QoL up to 8 weeks after treatment with the longitudinal study design. However, patients were not randomized to treatment group. While sex and family history differed at baseline amongst groups, they were not significant confounders. We also adjusted for baseline QoL scores during analysis.

We did not recruit any C0 or C1 patients as they tended to be asymptomatic and not seek treatment. We were unable to consider other risk factors such as strenuous physical activities or exercise as the patient population consisted mostly of housewives. Although this study was adequately powered to detect differences from baseline to follow-up in the overall sample, we had to pool sclerotherapy, EVLA and supportive treatment into one non-surgical group given their small sample sizes.

We could not assess treatment options such as MPFF and radiofrequency ablation as they were not available in Teaching Hospital Peradeniya. As a single-center study, our results cannot be generalized to other regions of Sri Lanka. It would be useful to further investigate any differences between surgical and non-surgical groups in a multi-center study.

This is the first study in Sri Lanka utilizing the CIVIQ-14, an internationally validated tool, to assess CVD-specific QoL. There was no internationally validated Sinhala CIVIQ-14 available, hence a Sinhala-speaking research assistant translated the CIVIQ-14 to Sinhala and we verified the Sinhala version with a sworn translator to minimize inaccuracies.

We did not assess other factors affecting QoL, such as disease recurrence, technical success or complications. A follow-up beyond 8 weeks is necessary to assess the maintenance of improvements in QoL after treatment.

Conclusion

CVD can affect QoL negatively if left untreated. Our study reaffirmed the importance of QoL as a clinical measure of treatment success. Both surgical and non-surgical treatments improved QoL significantly from before treatment to 4- and 8-weeks post-treatment. There were no significant improvements in the no-treatment group. Patient perceptions of CVD can influence treatment-seeking behaviors, highlighting the importance of understanding cultural perspectives when managing CVD.

Supplemental Material

sj-pdf-1-phl-10.1177_0268355521990972 - Supplemental material for Improvement in quality of life with treatment of chronic venous disease: A longitudinal observational study in Kandy, Sri Lanka

Supplemental material, sj-pdf-1-phl-10.1177_0268355521990972 for Improvement in quality of life with treatment of chronic venous disease: A longitudinal observational study in Kandy, Sri Lanka by Zhen Luan Low, John Carson Allen, Truls Østbye, Kuda Banda Galketiya, Si Ying Julienne Keong and Hiang Khoon Tan in Phlebology

Supplemental Material

sj-pdf-2-phl-10.1177_0268355521990972 - Supplemental material for Improvement in quality of life with treatment of chronic venous disease: A longitudinal observational study in Kandy, Sri Lanka

Supplemental material, sj-pdf-2-phl-10.1177_0268355521990972 for Improvement in quality of life with treatment of chronic venous disease: A longitudinal observational study in Kandy, Sri Lanka by Zhen Luan Low, John Carson Allen, Truls Østbye, Kuda Banda Galketiya, Si Ying Julienne Keong and Hiang Khoon Tan in Phlebology

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the AM-ETHOS Duke-NUS Medical Student Fellowship (Award Number: AM-ETHOS01/FY2019/16-A16) and the SingHealth Duke-NUS Global Health Institute Student Research Award (Award Number: SDGHI/FY2019/SRA/01/10-19).

Ethical approval

The study was approved by the Institutional Review Boards of the University of Peradeniya (2019/EC/64) and the National University of Singapore (N-19-088E). All patients provided written informed consent.

Guarantor

HT.

Contributorship

ZL, TO and HT researched literature, conceived the study and developed the study protocol. ZL, KG and JK were involved in gaining ethical approval, patient recruitment and data collection. JA, TO, HT and ZL were involved in data analysis. ZL wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.

Acknowledgements

The authors would like to thank the medical staff at Teaching Hospital Peradeniya and Ms. Dilani Rodrigo for their great help throughout this project.

ORCID iD

Zhen Luan Low

Supplemental material

Supplemental material for this article is available online.

References

Burnand

Wadoodi

Physiology of chronic venous insufficiency. In: Dalsing

Lemmon

(eds) The Layman’s handbook of venous disorders. East Dundee, IL: American Venous Forum, 2009, pp. 1–4.

Eklof

Rutherford

Bergan

, American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classificationet al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40: 1248–1252.

Fan

CM.

Epidemiology and pathophysiology of varicose veins. Tech Vasc Interv Radiol 2003; 6: 108–110.

Bradbury

Lambert

McLafferty

, et al. Chronic venous insufficiency presentation. In: Dalsing

Lemmon

(eds) The Layman’s handbook of venous disorders. East Dundee, IL: American Venous Forum, 2009, pp. 1–5.

Vuylsteke

Colman

Thomis

, et al. An epidemiological survey of venous disease among general practitioner attendees in different geographical regions on the globe: the final results of the vein consult program. Angiology 2018; 69: 779–785.

Nicolaides

Labropoulos

Burden and suffering in chronic venous disease. Adv Ther 2019; 36: 1–4.

Sagner

Arena

McNeil

, et al. Creating a pro-active health care system to combat chronic diseases in Sri Lanka: the Central role of preventive medicine and healthy lifestyle behaviors. Expert Rev Cardiovasc Ther 2016; 14: 1107–1117.

Mansilha

Sousa

Pathophysiological mechanisms of chronic venous disease and implications for venoactive drug therapy. Int J Mol Sci 2018; 19: 06–08.

Novak

Khimani

Kaye

, et al. Current therapeutic interventions in lower extremity venous insufficiency: a comprehensive review. Curr Pain Headache Rep 2019; 23: 16.

10.

Bogachev

Boldin

Turkin

PY.

Administration of micronized purified flavonoid fraction during sclerotherapy of reticular veins and telangiectasias: results of the national, multicenter, observational program VEIN ACT PROLONGED-C1. Adv Ther 2018; 35: 1001–1008.

11.

Launois

Le Moine

Lozano

, et al. Construction and international validation of CIVIQ-14 (a short form of CIVIQ-20), a new questionnaire with a stable factorial structure. Qual Life Res 2012; 21: 1051–1058.

12.

Branisteanu

Feodor

Baila

, et al. Impact of chronic venous disease on quality of life: results of vein alarm study. Exp Ther Med 2018; 17: 1091–1096.

13.

Kahn

M'Lan

Lamping

, et al. Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study. J Vasc Surg 2004; 39: 823–828.

14.

von Elm

Altman

Egger

, STROBE Initiativeet al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 2007; 4: e296.

15.

Launois

A quality of life tool kit in chronic venous disorders. Phlebolymphology 2015; 22: 33–41.

16.

Lee

Robertson

Boghossian

, et al. Progression of varicose veins and chronic venous insufficiency in the general population in the Edinburgh vein study. J Vasc Surg Venous Lymphat Disord 2015; 3: 18–26.

17.

Mansilha

Early stages of chronic venous disease: medical treatment alone or in addition to endovenous treatments. Adv Ther 2020; 37: 13–18.

18.

Jayasekara

Schultz

Health status, trends, and issues in Sri Lanka. Nurs Health Sci 2007; 9: 228–233.

19.

Launois

Mansilha

Jantet

International psychometric validation of the chronic venous disease quality of life questionnaire (CIVIQ-20). Eur J Vasc Endovasc Surg 2010; 40: 783–789.

20.

Vayssairat

Ziani

Houot

Placebo controlled efficacy of class 1 elastic stockings in chronic venous insufficiency of the lower limbs. J Mal Vasc 2000; 25: 256–262.

21.

Smith

Garratt

Guest

, et al. Evaluating and improving health-related quality of life in patients with varicose veins. J Vasc Surg 1999; 30: 710–719.

22.

Klem

Sybrandy

Wittens

CH.

Measurement of health-related quality of life with the Dutch translated Aberdeen varicose vein questionnaire before and after treatment. Eur J Vasc Endovasc Surg 2009; 37: 470–476.

23.

Leal

Couto

Pitta

GBB

, et al. Determination of the longitudinal sensitivity of the AVVQ-Brazil quality of life questionnaire to non-surgical treatment of chronic venous disease. J Vasc Bras 2019; 18: e20190048.

24.

Brittenden

Cotton

Elders

, et al. A randomized trial comparing treatments for varicose veins. N Engl J Med 2014; 371: 1218–1227.

25.

Rasmussen

Lawaetz

Serup

, et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up. J Vasc Surg Venous Lymphat Disord 2013; 1: 349–356.

26.

Biemans

Kockaert

Akkersdijk

, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg 2013; 58: 727–734.

27.

Siribumrungwong

Noorit

Wilasrusmee

, et al. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg 2012; 44: 214–223.

28.

van der Velden

Biemans

De Maeseneer

, et al. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg 2015; 102: 1184–1194.

29.

Grant

Onida

Davies

Genetics in chronic venous disease. Phlebology 2017; 32: 3–5.

30.

Lumley

Phillips

Aber

, et al. Experiences of living with varicose veins: a systematic review of qualitative research. J Clin Nurs 2019; 28: 1085–1099.

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